Drug News: Approvals, Warnings & Etc
January 2012
Updates on Drug Shortages. 1/23/2012. Acetylcysteine Inhalation Solution, Amphetamine Mixed Salts Immediate-Release Tablets, Atracurium besylate, Bleomycin Injection, Bupivacaine Hydrochloride Injection, Butorphanol injection, Calcitriol 1 mcg/mL Injection, Calcium Chloride Injection, Chromic Chloride Injection, Desmopressin Injection, Dextroamphetamine Tablets, Diltiazem Injection, Doxorubicin Liposomal (Doxil) Injection, Ketorolac Injection, Mebaral (mephobarbital) 32mg tablets and 50mg tablets and 100mg tablets, Magnesium Sulfate Injection, Methotrexate Injection, Methotrexate Injection-Preservative Free, Methylphenidate HCl, Metoclopramide injection, Midazolam Injection, Morphine Sulfate Injection, Mustargen (mechlorethamine HCl) injection, Nalbuphine Injection, Ondansetron Injection 2 mg/mL, Potassium Phosphate, Telavancin (Vibativ) Injection, Tobramycin Solution for Injection, Vincristine Sulfate Injection. Source: FDA
Generic Drug Approvals by the FDA. 1/23/2012. Alfuzosin Hydrochloride, Argatroban, Armodafinil, Docetaxel, Metoprolol Tartrate and Hydrochlorothiazide, Morphine Sulfate, Oxycodone Hydrochloride, Sodium Chloride, Subsys, Twynsta, Voraxaze. Source: FDA
New risk factor for Progressive Multifocal Leukoencephalopathy. 1/20/2012. Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease. The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML, which include longer duration of Tysabri treatment, especially beyond 2 years, and Prior treatment with an immunosuppressant medication (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil). Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. Source: FDA
Recall of Perfect Image Solutions Topical Hair Regrowth Products. 1/20/2012. Perfect Image Solutions recalled several topical hair regrowth products because they are deemed "unapproved new drugs" under FDA regulations, and may present potential health hazards. Use of these topical products containing Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption, which is increased by skin abrasions or irritations, such as psoriasis or sunburn. Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging. The recalled products include all lots of the following: Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml; Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL. Source: FDA
Voraxaze Approved to Treat Patients with Toxic Methotrexate Levels. 1/17/2012. Voraxaze (glucarpidase) has been approved to treat patients with toxic levels of methotrexate, commonly used cancer chemotherapy drug, in their blood due to kidney failure. Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts. Voraxaze is an enzyme that works by breaking methotrexate down to a form that can be eliminated from the body and is administered intravenously.The most common side effects observed in greater than one percent of patients in the clinical study were low blood pressure, headache, nausea, vomiting, flushing, and paraesthesia. Source: FDA
New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin). 1/13/2012. Two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin), so a new Boxed Warning highlighting this risk has been added to the drug label. The signs and symptoms of PML may develop over the course of several weeks or months and may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body. A new contraindication warning against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary toxicity has also been added to the drug label. Source: FDA
Potential Safety Risk Associated with Certain Opiate Products Made for Endo Pharmaceuticals. 1/09/2012. FDA's inspection of the Novartis manufacturing facility found a packaging problem that may result in a pill, tablet or caplet getting mixed in with a different prescription and poses a potential safety risk associated with certain opiate products manufactured for Endo Pharmaceuticals by Novartis Consumer Health. The FDA is working with Novartis and Endo to resolve the packaging problem, however if patients find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills. Source: FDA
Doribax (doripenem) Clinical Trial Terminated. 1/05/2012. A recent clinical trial evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, was stopped early as it demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. Healthcare professionals should be aware that Doribax is not approved to treat any type of pneumonia, nor is it approved for doses greater than 500 mg every eight hours. Doribax is still considered safe and effective for its approved indications, which include treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis. The recommended dose of Doribax is 500 mg every eight hours intravenously, given over 1 hour, for a total of 5-14 days in adults. Source: FDA
October 2011
ADHD Medications and Cardiovascular Events. 11/01/2011. A recent study in children and young adults treated with stimulant medications for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between the use of these drugs, including atomoxetine and pemoline, and adverse cardiovascular events. Source: FDA
Generic Olanzapine Approved to Treat Schizophrenia and Bipolar Disorder. 10/24/2011. The FDA approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder. Serious risks of olanzapine include, hyperglycemia, increased cholesterol and triglycerides, and weight gain. It can also raise the risk of death in elderly people who have lost touch with reality due to dementia, and is not approved for such use. Source: FDA
Voluntary Market Withdrawal of Xigris [drotrecogin alfa (activated)]. 10/25/2011. Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] because in a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. Source: FDA
Onfi Approved to Treat Severe Type of Seizures. 10/24/2011. The FDA has approved Onfi tablets (clobazam) for use as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. Common adverse reactions reported by patients taking Onfi compared to those taking an inactive tablet (placebo) included somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, insomnia, aggression, fatigue, upper respiratory tract infection, irritability, vomiting, dysphagia, ataxia, bronchitis, and pneumonia. Like other antiepileptic drugs, Onfi may increase the risk of suicidal thoughts or behaviors in a very small number of people taking the drug. Patients taking antiepileptic drugs should be monitored for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. Source: FDA
Update of Chantix (varenicline) and Risk of Neuropsychiatric Adverse Events. 10/24/2011. In two studies of the smoking cessation drug Chantix (varenicline), the FDA found no difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy. However, both studies had a number of study design limitations, and although they did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix. Source: FDA
Nostrilla Nasal Decongestant Recal. 10/21/2011. Insight Pharmaceuticals, LLC recalled one lot #11G075 of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia, which may cause serious infection in individuals with a compromised immune system or chronic lung condition. Source: FDA
Methylene Blue (methylthioninium chloride) and Serotonergic Psychiatric Medications. 10/20/2011. The FDA is updating the public on the potential drug interaction between methylene blue and serotonergic psychiatric medications. Most reported cases occurred in patients given serotonergic psychiatric medications and methylene blue occurred in the context of parathyroid surgery, which involved the intravenous administration of methylene blue as a visualizing agent, and it is not known whether there is a risk of serotonin syndrome in patients taking serotonergic psychiatric medications who are given methylene blue by other routes or at intravenous doses lower than 1 mg/kg. These cases also occurred in patients taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI) and it is unclear at this time whether linezolid administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk. Source: FDA
Linezolid (Zyvox) and Serotonergic Psychiatric Medications Interaction. 10/20/2011. The FDA is updating the public about the possible interaction between linezolid (Zyvox) and serotonergic psychiatric medications to cause serotonin syndrome. Most of the reported cases have occurred in patients taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI) and it is unclear at this time whether linezolid administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk. Source: FDA
Ferriprox (deferiprone) Approved to Treat Iron Overload Due to Blood Transfusions. 10/14/2011. Ferriprox (deferiprone) has been approved to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. The most common side effects include nausea, vomiting, abdominal and joint pain, urine discoloration (chromaturia), a decrease in the number of white blood cells (neutropenia), and an increase in the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts. The most serious side effect seen in about two percent of patients treated with Ferriprox was the development of agranulocytosis, a serious and potentially life-threatening reduction in the number of granulocytes. Source: FDA
Sprycel (dasatinib) and Risk of Pulmonary Arterial Hypertension. 10/11/2011. The FDA is warning that the leukemia drug Sprycel (dasatinib) may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). Patients developing these symptoms should notify their healthcare provider who should rule out other causes and then consider a diagnosis of Sprycel-associated PAH. Source: FDA
Combination Therapy Juvisync (sitagliptin and simvastatin) Approved. 10/07/2011. Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet, has been approved as the first combination drug to treat type 2 diabetes and high cholesterol in one tablet. The most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache,muscle and stomach pain, constipation, and nausea. Source: FDA
FDA Approves Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray to Replace Aerosols. 10/07/2011. The FDA has approved Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for patients with chronic obstructive pulmonary disease (COPD) to replace their regular aerosol bronchodilator as they are phased. Source: FDA
Cialis Approved to Treat Benign Prostatic Hyperplasia. 10/06/2011. Cialis (tadalafil) has been approved to treat the signs and symptoms of benign prostatic hyperplasia (BPH), as well as BHP and erectile dysfunction (ED) when the conditions occur simultaneously. Cialis should not be used in patients taking nitrates because the combination can cause an unsafe decrease in blood pressure. The use of Cialis in combination with alpha blockers may also risk a lowering of blood pressure. Source: FDA
Updates on Drug Shortages. 10/05/2011. Acetylcysteine
Inhalation Solution, Alcohol Dehydrated (Ethanol
> 98%), Amikacin
Injection, Aminocaproic Acid, Aquasol A, Bleomycin Injection, Calcitriol 1 mcg/mL Injection,
Buprenorphine Injection, Cyanocobalamin injection, Cytarabine Injection, Daunorubicin hydrochloride solution for injection,
Diltiazem Injection, Doxorubicin (adriamycin) lyophilized powder, Doxorubicin Solution
for Injection, Doxorubicin Liposomal (Doxil) Injection, Etoposide Injection,
Fosphenytoin Sodium Injection, Lorazepam Injection, Leucovorin Calcium
Lyophilized Powder for Injection, Mitomycin Powder for Injection, Multi-Vitamin
Infusion,
Nalbuphine Injection, Norepinephrine Bitartrate
Injection, Ontak
injection, Paclitaxel Injection, Sodium Chloride 14.6% Injection, Thiotepa Injection,
Vecuronium Injection, Vincristine Sulfate Injection. Source: FDA
Generic Drug Approvals by the FDA. 10/05/2011. Digoxin Oral Solution, Doxercalciferol Capsules, Enoxaparin Sodium Subcutaneous Injection, Ethinyl Estradiol Chewable Tablets, Ferrous
Fumarate Chewable Tablets, Galantamine Hydrobromide
Tablets, Glycopyrrolate Injection, Levetiracetam Tablet, Levetiracetam Extended-Release Tablets, Levofloxacin and Dextrose
(5%) in Plastic Container Injection, Loxapin Succinate Capsules, Nafcillin Sodium Injection, Naproxen
Delayed-Release Tablets, Naproxen Sodium Tablets, Norethindrone Tablets, Norethindrone Chewable Tablets, Paclitaxel Injection, Ranitidine Hydrochloride Syrup, Simvastatin
Tablets, Tamoxifen Citrate Tablets, Vancomycin Hydrochloride
Injection. Source: FDA
September 2011
Remicade (infliximab) Approved to
Treat Moderately to Severely Active Ulcerative Colitis. 9/23/2011. The FDA approved Remicade
(infliximab), tumor necrosis factor (TNF) blocker, to treat moderately to
severely active ulcerative colitis (UC) in children 6 years and older who
have had inadequate response to conventional therapy. Remicade reduces signs and symptoms
of UC and induces and maintains clinical remission in these patients. Remicade
carries a Boxed Warning for risk of serious infections including tuberculosis
and infections caused by viruses, fungi or bacteria, and unusual cancers
including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma.
Children should have all of their vaccines brought up to date before starting
treatment with Remicade and should not receive live vaccines while taking
Remicade. The most common side effects of Remicade are worsening of UC, upper
respiratory infections, infusion-related reactions, and headache. Source: FDA
Soliris (eculizumab) Approved to Treat Atypical Hemolytic Uremic
Syndrome. 9/23/2011. The FDA has approved
Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome
(aHUS). Soliris
is a targeted therapy that works by inhibiting proteins that play a role in
aHUS. The most common side effects seen
in patients treated with Soliris for aHUS included hypertension, diarrhea,
headache, anemia, vomiting, nausea, upper respiratory and urinary tract
infections, and leucopenia. Source: FDA
Epinephrine CFC
Metered-Dose Inhalers Phasing Out. 9/22/2011. Epinephrine metered dose inhalers
(MDIs) that contain chlorofluorocarbons (CFC) are being phased out and will not
be sold in the United States after December 31, 2011. Source: FDA
New Drug Applications for
Enoxaparin Sodium for Injection. 9/19/2011. The FDA has approved
abbreviated new drug applications for enoxaparin sodium for injection, generic
versions of Lovenox. Source: FDA
Updates on Drug Shortages. 9/16/2011. Acetylcysteine
Inhalation Solution, Aminocaproic
Acid,
Bleomycin Injection, Cerezyme (imiglucerase for injection), Cytarabine
Injection, Fabrazyme (agalsidase beta), Foscarnet Sodium Injection, Furosemide Injection, Isoniazid Tablets, Magnesium Sulfate Injection,
Nalbuphine Injection, Procainamide HCL Injection, Propofol Injection, Sodium
Phosphate Injection, Streptomycin for Injection, USP. Source: FDA
Generic Drug Approvals by the FDA. 9/16/2011. Eszopiclone Tablets, Felbamate Tablets, Haloperidol
Injection, Levetiracetam
Extended-Release Tablets. Source: FDA
Qualitest
Pharmaceuticals Oral Contraceptives Recall. 9/16/2011. Qualitest Pharmaceuticals issued a
nationwide, retail-level recall of multiple lots of oral contraceptives because
select blisters were rotated 180 degrees within the card, reversing the weekly
tablet orientation and making the lot number and expiry date no longer visible. This packaging error may result in the
daily regimen for these products being incorrect and could leave women
without adequate contraception, and at risk for unintended pregnancy. Source: FDA
Abnormal Heart
Rhythms Associated with Zofran (ondansetron). 9/15/2011. The FDA is informing
the public of an ongoing safety review of the anti-nausea drug Zofran
(ondansetron, ondansetron hydrochloride and their generics) as it may cause prolongation of the QT interval of the
electrocardiogram which can lead to abnormal heart rhythm including Torsade de
Pointes, which can be fatal. Patients
at particular risk for developing Torsade include those with underlying heart
conditions, such as congenital long QT syndrome, those who are predisposed to
low levels of potassium and magnesium in the blood, and those taking other
medications that lead to QT prolongation. Source: FDA
Updated Boxed
Warning for Tumor Necrosis Factor-alpha (TNFα) blockers. 9/07/2011. The Boxed Warning for the
entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to
include the risk of infection from Legionella and Listeria. Source: FDA
Serious allergic
reactions reported with the use of Saphris (asenapine maleate). 9/01/2011. The FDA is warning the public that
serious allergic reactions have been reported with the use of the antipsychotic
medication Saphris (asenapine maleate) and it should not be used in patients
with a known hypersensitivity to the drug.
Signs and symptoms of hypersensitivity reactions may include
anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue,
difficulty breathing, wheezing, or rash. Healthcare
professionals should be aware of the risk of hypersensitivity
reactions with Saphris and know how to
recognize the signs and symptoms of a serious allergic reaction. Patients should seek emergency medical
attention immediately if they develop any signs and symptoms of a serious
allergic reaction while taking Saphris. Source: FDA
New
Contraindication and Label Warnings for Reclast (zoledronic acid). 9/01/2011. The drug label for Reclast
(zoledronic acid) has been updated regarding the risk of renal failure in
patients with a history of or risk factors for renal impairment. The revised label states that
Reclast should not be used or is contraindicated in patients with
creatinine clearance less than 35 mL/min or in patients with evidence of acute
renal impairment. The label also recommends that healthcare professionals
screen patients prior to administering Reclast in order to identify at-risk
patients. Source: FDA
August
2011
Infection Risk
from Repackaged Avastin Intravitreal Injections. 8/30/2011. The FDA is alerting health care
professionals that intravitreal injections of Avastin (bevacizumab) repackaged
in Hollywood, Florida have caused a cluster of serious Streptococcus
endophthalmitis eye. The
agency and Florida health officials continue to investigate the cause of the
infection. While the investigation is not yet complete, the common link
for the infections is the pharmacy that repackaged the Avastin and the single
lot of Avastin used in the re-packaging. Source: FDA
Xalkori Approved for a Specific
Type of Late-Stage Lung Cancer. 8/26/2011. Xalkori (crizotinib) has been
approved by the FDA to treat certain patients with late-stage, non-small cell
lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK)
gene. Xalkori is being approved with a companion first-of-a-kind genetic test
called the Vysis ALK Break Apart FISH Probe Kit, that will help determine if a
patient has the abnormal ALK gene.
The most common side effects include vision disorders, nausea,
diarrhea, vomiting, edema, and constipation. Xalkori use has also been
associated with pneumonitis, which can be life-threatening and indicates that
treatment with Xalkori should be stopped permanently. The drug should not be
used in pregnant women. Source: FDA
Zelboraf (vemurafenib) Approved to
treat Metastatic or Unresectable Melanoma. 8/17/2011. The FDA has approved approved
Zelboraf (vemurafenib) to treat patients with metastatic or unresectable
melanoma. Zelboraf
is specifically indicated for the treatment of patients with melanoma whose
tumors express a gene mutation called BRAF V600E and is being approved with a
first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test. The most
common side effects included joint pain, rash, hair loss, fatigue, nausea, and
skin sensitivity when exposed to the sun. About 26 percent of patients
developed a skin-related cancer called cutaneous squamous cell carcinoma, which
was managed with surgery. Source: FDA
Adcetris (brentuximab vedotin) Approved
to Treat Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma. 8/19/2011. The FDA has approved
Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and systemic
anaplastic large cell lymphoma.
Adcetris is an antibody-drug conjugate that combines an antibody
and drug, allowing the antibody to direct the drug to a target on lymphoma
cells known as CD30. Adcetris
is to be used in patients with HL whose disease has progressed after autologous
stem cell transplant or after two prior chemotherapy treatments for those who
cannot receive a transplant. The most common side effects experienced were
neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper
respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia.
Pregnant women should be aware that Adcetris might cause harm to their unborn
baby. Source: FDA
Abnormal Heart
Rhythms Associated with High Doses of of Celexa (citalopram hydrobromide). 8/24/2011. The
FDA is announcing that the antidepressant Celexa (citalopram
hydrobromide) should no longer be used at doses greater than 40 mg per day
because it can cause prolongation of the QT interval of the electrocardiogram
which can lead to abnormal heart rhythm including Torsade de Pointes, which can
be fatal. Patients
at particular risk for developing prolongation of the QT interval include those
with underlying heart conditions and those who are predisposed to low levels of
potassium and magnesium in the blood. Source: FDA
Botox Approved
to Treat Urinary Incontinence Related to Neurological Conditions. 8/25/2011. The FDA approved Botox
(onabotulinumtoxinA) injection using cystoscopy to treat urinary incontinence
in people with neurologic conditions such as spinal cord injury and multiple
sclerosis who have overactivity of the bladder. The injection results in
relaxation of the bladder, an increase in its storage capacity and a decrease
in urinary incontinence. The most common adverse reactions were urinary tract
infection and urinary retention. Source: FDA
Firazyr
Approved to Treat Acute Attacks of Hereditary Angioedema. 8/25/2011. The FDA has approved
Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary
angioedema (HAE) in people ages 18 years and older. Firazyr is the third
drug approved in the United States to treat HAE attacks and the most common
side effects reported were injection site reactions, fever, increased liver
enzymes, dizziness, and rash.Source: FDA
Updated Pioglitazone Labels. 8/04/2011. Drug labels for pioglitazone-containing
medicines have been updated to include safety information that use for more
than one year may be associated with an increased risk of bladder cancer. The
labels also recommend that healthcare professionals should not use pioglitazone
in patients with active bladder cancer and to use it with caution in patients
who have a prior history of bladder cancer. Source: FDA
Vasopressin Injection Recall. 8/04/2011. American Regent, Inc. has issued a
nationwide voluntary recall of multiple lots of Vasopressin Injection, USP
because some vials may not maintain potency throughout their shelf-life. For a
complete listing of affected lots see the company press release. Source: FDA
Chronic, High Doses of Diflucan (Fluconazole) Associated with Birth Defects. 8/03/2011. Chronic, high doses (400-800 mg/day)
of the antifungal drug Diflucan (fluconazole) may be associated with a rare and
distinct set of birth defects in infants whose mothers were treated with the
drug during the first trimester of pregnancy. This risk does not appear to be associated with a
single, low dose of fluconazole 150 mg. Source: FDA
July
2011
CNS Reactions When Linezolid (Zyvox) is Given to Patients Taking Serotonergic
Psychiatric Medications. 7/26/2011. Serious centeral nervous system reactions have
been reported when the antibacterial drug linezolid (Zyvox) is
given to patients taking serotonergic psychiatric medications. Linezolid inhibits the action of
monoamine oxidase A, an enzyme responsible for breaking down serotonin in the
brain, and it is believed that when linezolid is given to patients taking
serotonergic psychiatric medications, high levels of serotonin can build up in
the brain, causing toxicity known as Serotonin Syndrome. Signs and symptoms of
Serotonin Syndrome include mental changes (confusion, hyperactivity, memory
problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea,
trouble with coordination, and fever. Source: FDA
CNS Reactions When Methylene Blue is Given to Patients Taking Serotonergic Psychiatric Drugs. 7/26/2011. Serious centeral nervous system reactions have
been reported when the drug methylene blue is given to
patients taking serotonergic psychiatric medications. Linezolid inhibits the action of
monoamine oxidase A, an enzyme responsible for breaking down serotonin in the
brain, and it is believed that when methylene blue is given to patients taking
serotonergic psychiatric medications, high levels of serotonin can build up in
the brain, causing toxicity known as Serotonin Syndrome. Signs and symptoms of Serotonin
Syndrome include mental changes (confusion, hyperactivity, memory problems),
muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble
with coordination, and fever. Source: FDA
CardioGen-82 Recall. 7/26/2011. The
FDA is alerting healthcare professionals to stop using CardioGen-82
for cardiac positron emission tomography (PET) scans as there is a potential
for inadvertent, increased radiation exposure. The manufacturer, Bracco Diagnostics, Inc. has decided
to voluntarily recall CardioGen-82. Source: FDA
FDA Warns
Against Evital Use. 7/28/2011. The FDA is warning consumers
not to use the emergency birth control medicine labeled as Evital as it is not
approved by the FDA and may be a counterfeit version of the "morning after
pill" and may not be safe or effective in preventing pregnancy. Source: FDA
Chantix
(varenicline) Label Change. 7/22/2011. The FDA has approved an updated
drug label for Chantix (varenicline) to include information about the efficacy
and safety of the drug in patients with cardiovascular disease and those with
chronic obstructive pulmonary disease (COPD). The updated label now also
includes alternative directions for patients to select a quit smoking date. Source: FDA
Multaq
(dronedarone) and Increased Risk of Death and Cardiovascular Events. 7/21/2011. The FDA is reviewing the data from a clinical
trial of the antiarrhythmic drug Multaq (dronedarone) in patients
with permanent atrial fibrillation which was stopped early after the
data revealed a two-fold increase in death, stroke, and heart failure in
patients receiving Multaq as compared to placebo. At this time, patients
taking Multaq should talk to their healthcare professional about whether they
should continue to take Multaq for non-permanent atrial fibrillation. Source: FDA
Brilinta (ticagrelor) Approved. 7/20/2011. The FDA has approved
the blood-thinning drug Brilinta (ticagrelor) with a Risk Evaluation and
Mitigation Strategy to reduce cardiovascular death and heart attack in patients
with acute coronary syndromes (ACS) by preventing the formation of new blood
clots, thus maintaining blood flow in the body to help reduce the risk of
another cardiovascular event. Aspirin doses above 100 milligrams per day
decrease the effectiveness of the medication and the most commonly reported
side effects were bleeding and difficulty breathing (dyspnea). Source: FDA
Increased
Radiation Exposure with CardioGen-82. 7/15/2011. The FDA is warning about
the potential for inadvertent, increased radiation exposure in patients who
underwent or will be undergoing cardiac positron emission tomography (PET)
scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (manufactured
by Bracco Diagnostics, Inc.). The
FDA has received reports of two patients who received more
radiation than expected from CardioGen-82 due to strontium isotopes which may
have been inadvertently injected into the patients due to a "strontium
breakthrough" problem with CardioGen-82.
The FDA is actively investigating the root cause of this failure
with CardioGen-82 and will promptly notify the public with updates. Source: FDA
Tamiflu Changes. 7/11/2011. The FDA has made the following changes to the
influenza drug Tamiflu (oseltamivir phosphate) in order to
reduce the possibility of prescribing and dosing confusion: concentration
changed from 12 mg/ml to 6 mg/ml, measurement of oral dosing device changed
from milligrams to milliliters, dosing table changed to include column for the
volume based on the new concentration, container labels and carton packaging
revised, and compounding instructions for pharmacies to prepare a 6 mg/mL oral
suspension from Tamiflu capsules in an emergency situation revised. Source: FDA
Sibutramine
Found in Weight Loss Products. 7/08/2011. The FDA warns
against the use of the weight loss products "Slim Forte Slimming
Capsules," "Slim Forte Double Power Slimming Capsules," "Slim Forte Slimming Coffee," and "Botanical Slimming Soft
Gel," as lab analysis found them to contain sibutramine, which substantially
increases the blood pressure and pulse rate in some patients and may present a
significant risk for patients with a history of coronary artery disease,
congestive heart failure, arrhythmias, or stroke. These products may also interact in life threatening
ways with other medications a consumer may be taking. Source: FDA, FDA
June
2011
Impaired
Cognitive Development in Children Born
to Mothers Who Took Valproate Products During Pregnancy. 6/30/2011. The results of epidemiologic
studies have shown that children born to mothers who took valproate sodium or
related products throughout their pregnancy tend to score lower on cognitive
tests than children born to mothers who took other anti-seizure medications during
pregnancy. The FDA will be adding information about the risk of lower cognitive
test scores to the valproate product labels in the Warnings and Precautions
section, the Use in Specific Populations: Pregnancy section, and to the
Medication Guides that are being developed for the valproate drug products. Source: FDA
Endocet
(Oxycodone/Acetaminophen) Recall. 6/27/2011. A nationwide recall
has been issued for Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325
mg, because some bottles may contain different strength tablets, resulting in unintentional
administration of tablets with increased acetaminophen content which may cause
liver toxicity. Source: FDA
Butalbital,
Acetaminophen, Caffeine Tablets, Hydrocodone Bitartrate Recall. 6/27/2011. A recall has been issued to the
retail level of specific lots of Butalbital, Acetaminophen, and Caffeine
Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility
that the recalled bottles may contain incorrect tablets, and patients may
unintentionally take butalbital and caffeine instead of hydrocodone. Patients who were receiving hydrocodone for chronic pain
might experience worsening pain and withdrawal symptoms as a result of this
substitution. The affected products are: Butalbital, Acetaminophen, and
Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers
C0390909A, C0400909A, C0410909A, C0590909B and Hydrocodone Bitartrate and
Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot
Numbers C0390909A, C0400909A, C0410909A, C0590909B. Source: FDA
Modified Dosing
Recommendations for Use of
Erythropoiesis-Stimulating Agents in Chronic Kidney Disease. 6/24/2011. The FDA has modified
recommendations for more conservative dosing of
Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney
disease (CKD) because of data showing increased risks of cardiovascular events
with ESAs in this patient population.
Revised labels now recommend patients with CKD to consider
starting ESA treatment when the hemoglobin level is less than 10 g/dL and to use
the lowest dose of ESA sufficient to reduce the need for red blood cell
transfusions. Source: FDA
Generic Version
of Levaquin (levofloxacin) Approved. 6/20/2011. The FDA has approved the first generic version
of Levaquin (levofloxacin), an antibiotic approved to treat
specific bacterial infections of the skin, sinuses, kidneys, bladder, and
prostate, certain bacterial infections that cause bronchitis or pneumonia, and
exposure to inhalational anthrax.
Levofloxacin belongs to a class of drugs called
fluoroquinolones, which are associated with an increased risk of tendinitis and
tendon rupture, and the drug may also worsen muscle weakness in people with
myasthenia gravis. Source: FDA
Risperidone
Recall. 6/20/2011. A recall has been issued for specific lots of Risperdal
(risperidone) 3mg tablets and risperidone 2mg tablets stemming from consumer
reports of an uncharacteristic odor thought to be caused by trace amounts of
TBA (2,4,6 tribromoanisole), a chemical preservative byproduct not considered
to be toxic, however a small number of patients have reported temporary
gastrointestinal symptoms. The affected
products include Risperdal lot 0GG904 and risperidone lot OIG175. Source: FDA
American Regent
Injectable Products Recall Expanded. 6/16/2011. American Regent injectable products recall (due
to visible particulates consistent with glass delamination) has been expanded
to include the following: Concentrated Sodium Chloride
Injection, USP 23.4%, 30 mL Single Dose Vials (Lot #0362); Methyldopate HCL
Injection, USP 5ml Single Dose Vial; Caffeine & Sodium Benzoate Injection,
USP, 250 mg/mL, 2 mL Single Dose Vial; Ammonium Molybdate Injection, USP
(Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial; Dexamethasone Sodium
Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple
Dose Vials; Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple
Dose Vials; Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single
Dose Vials and 100mL Pharmacy Bulk Packages; Sodium Thiosulfate Injection USP
10%; Potassium Phosphates Injection, USP. Source: FDA
Chantix (varenicline) May Increase
the Risk of Cardiovascular Events. 6/16/2011. Chantix (varenicline), a smoking
cessation aid, may be associated with a small, increased risk of certain
cardiovascular adverse events, including heart attack, in patients who have
cardiovascular disease. Source: FDA
Nulojix
Approved to Prevent Rejection in Kidney Transplant Patients. 6/15/2011. The FDA approved Nulojix
(belatacept), a selective T-cell costimulation blocker, for use with other
immunosuppressants to prevent acute rejection in adult patients who have had a
kidney transplant. Nulojix is given
through 30 minute intravenous infusions, works with other immunosuppressants.
Nulojix increases the risk of developing post-transplant lymphoproliferative
disorder (PTLD), which is higher for transplant patients who have never been
exposed to Epstein-Barr virus (EBV) and should only be given to patients who
have been exposed to EBV. Common adverse effects include anemia, constipation,
kidney or bladder infection, and swollen legs, ankles, or feet. Source: FDA
Indomethacin for Injection Recall. 6/15/2011. Bedford Laboratories issued a
nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose
Vial (NDC #55390-299-01, Lot 1948138, Exp. Date September 2011) as it may
contain particulate matter which has been identified as active drug substance
and not foreign material or contamination. Particulate matter may provoke an
immune reaction or lead to microinfarcts. Source: FDA
Pioglitazone
May Increase Risk of Bladder Cancer. 6/15/2011. The FDA is informing the public that use of
the diabetes medication Actos (pioglitazone) for more than one year may be
associated with an increased risk of bladder cancer. This safety information is
based on FDA's review of data from a planned five-year interim analysis of an
ongoing, ten-year epidemiological study. The five-year results showed that
although there was no overall increased risk of bladder cancer with
pioglitazone use, an increased risk of bladder cancer was noted among patients
with the longest exposure to pioglitazone, and in those exposed to the highest
cumulative dose of pioglitazone. Source: FDA
Potiga Approved
to Treat Siezures Associated with Epilepsy. 6/13/2011. The FDA has approved the use of Potiga
(ezogabine) tablets for the treatment of partial seizures in epilepsy patients. Potiga is a neuronal potassium
channel opener, which may act as an anticonvulsant by reducing excitability
through the stabilization of neuronal potassium channels in an "open" position,
although the mechanism of action is not firmly established. The most common
adverse effects include dizziness, fatigue, confusion, spinning sensation
(vertigo), tremor, problems with coordination, double vision, problems paying
attention, memory impairment, lack of strength, and double-vision, but Potiga
can also cause urinary retention or neuro-psychiatric symptoms. Source: FDA
5-ARIs Increase
Risk of High-Grade Prostate Cancer. 6/09/2011. The Warnings and Precautions
section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of
drugs, which include finasteride and dutasteride, has been revised to include
new safety information about the increased risk of being diagnosed with
high-grade prostate cancer. The risk appears
to be low but should be weighed as a potential risk when deciding to treat with
5-ARIs in men. Source: FDA
Simvastatin Dose Limitations and Contraindications. 6/08/2011. Due to the increased risk of myopathy
associated with high doses and drug interactions, the FDA is recommending limiting
the use of simvastatin
(Zocor) 80 mg to patients who have been taking this dose for 12 months or more
without evidence of muscle injury.
This dose should not be started in new patients or patients already taking
lower doses of the drug. New contraindications and dose limitations for
using simvastatin with certain medicines will be
added to the drug label. Source: FDA
Aidapak Services
Product Recall. 6/03/2011. Aidapak Services has issued a
nationwide recall of multiple repackaged drug products due to a potential cross
contamination of non-penicillin drug products, which, if used, could
potentially cause anaphylactic reaction in patients with known hypersensitivity
to beta-lactam or penicillin products.
For full list of recalled products, see firm press release. Source: FDA
Angiotensin Receptor Blockers Do
Not Increase Risk of Caner. 6/02/2011. The FDA has concluded its review of angiotensin
receptor blockers (ARBs) and determined that ARB medications do not increase a
patient's risk of developing cancer. Source: FDA
May
2011
Updates on Drug Shortages. 5/31/2011. Acetylcysteine inhalation solution,
Amikacin Injection, Amino Acid Injection, Ammonium
molybdate injection, Amphetamine Mixed Salts, ER Capsules, BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60), Bleomycin Injection, Bumetanide
Injection, Calcitriol
1 mcg/mL Injection, Calcium Chloride Injection, Cisplatin
injection 1 mg/mL solution, Cytarabine injection (powder for reconstitution), Daunorubicin
hydrochloride solution for injection, Dexamethasone Injection, Digoxin
Injection, Diltiazem Injection 5 mg/mL, Doxorubicin (adriamycin) lyophilized
powder and solution for injection, Erythromycin lactobionate injection, Etoposide solution for injection, Fentanyl Transdermal System, Leucovorin Calcium Lyophilized Powder for Injection, Levoleucovorin (Fusilev) 50 mg
single use vials, Lorazepam Injection, Haloperidol Decanoate Injection, Methylphenidate HCl, Nalbuphine
Injection, Nitroglycerin in Dextrose 5%, Norepinephrine Bitartrate Injection, Pentosan Polysulfate
sodium 100mg capsules, Potassium Phosphate, Propofol Injection, Renacidin
Irrigation NDC 00327-0011-05, Sodium Chloride 14.6%, Sodium Phosphate
Injection, Succinylcholine
Injection, Thiotepa for Injection, Vecuronium Injection, Vincristine 1 mg/mL. Source: FDA
Generic Drug Approvals by the FDA. 5/31/2011. Bromfenac
Sodium Ophthalmic Solution, Budesonide
Capsules, Dexamethasone Elixir, DOCEFREZ
(docetaxel) Injection, Eszopiclone Tablets, Gemcitabine
Injection, Incivek (telaprevir)
Tablets, Irinotecan Hydrochloride Injection, Lamivudine
and Zidovudine Tablets, Meprobamate Tablets, Naproxen
Sodium Tablets, Nitrofurantoin Oral Suspension, Octreotide Acetate (Preservative Free) Injection, Piperacillin and Tazobactam Injection, Potassium Chloride Extended-Release Capsules, Ranitidine Hydrochloride Tablets, Risperidone Oral
Solution, Sodium Polystyrene Sulfonate Suspension, Victrelis
(boceprevir) Capsules, Warfarin Sodium Tablets. Source: FDA
Incivek
(telaprevir) Approved to Treat Chronic Hepatitis C. 5/23/2011. The FDA has approved Incivek (telaprevir), a protease inhibitor, for use with
interferon therapy made up of peginterferon alfa and ribavirin to treat chronic
hepatitis C infection in adults have either not received interferon-based drug
therapy for their infection or who have not responded adequately to prior
therapies. Incivek is a pill taken three times a day with food in
combination with peginterferon alfa and ribavirin for the first 12 weeks. The most
commonly reported side effects in patients receiving Incivek in combination
with peginterferon alfa and ribavirin include rash, anemia, nausea, fatigue,
headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Source: FDA
Dificid
(fidaxomicin) Tablets Approved to Treat Clostridium Difficile-Associated
Diarrhea. 5/27/2011. The
FDA has approved Dificid (fidaxomicin) tablets, a
macrolide antibacterial, for the treatment of Clostridium difficile-associated
diarrhea (CDAD). It should be
taken two times a day for 10 days with or without food. The
most common side effects included nausea, vomiting, headache, abdominal pain,
and diarrhea. Source: FDA
Edurant
(rilpivirine) Approved for HIV Treatment. 5/20/2011. The FDA has approved Edurant (rilpivirine), a non-nucleoside reverse
transcriptase inhibitor (NNRTI) which blocks HIV viral replication, in
combination with other antiretroviral drugs for the treatment of HIV-1
infection in adults who have never taken HIV therapy (treatment-naïve). Edurant is administered as a
pill taken once daily with food. The most commonly reported side effects
included depression, insomnia, headache and rash. Source: FDA
Sutent
(sunitinib) Approved to Treat Progressive Neuroendocrine Cancerous Tumors of
the Pancreas. 5/20/2011. The FDA has approved Sutent (sunitinib) to treat patients with progressive
neuroendocrine cancerous tumors located in the pancreas that cannot be removed
by surgery or that have spread to other parts of the body. The most commonly reported
side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood
pressure, asthenia, abdominal pain, changes in hair color, stomatitis, and
neutropenia. Source: FDA
REMS Updated to
Restrict Access to Rosiglitazone-Containing Medicines. 5/18/2011. The FDA has updated the REMS for rosiglitazone-containing medicines (Avandia, Avandamet, and
Avandaryl) to include a restricted access and distribution program. The restrictions are based on data that suggested
an elevated risk of heart attacks associated with rosiglitazone use and require
both patients and healthcare providers to enroll in a special program in order
to prescribe and receive these drugs. Source: FDA
Victrelis
(boceprevir) Approved to Treat Chronic Hepatits C. 5/13/2011. The FDA has approved Victrelis (boceprevir) in combination with peginterferon alfa
and ribavirin to treat adult chronic hepatitis C patients who still have some
liver function and who have either not been previously treated with drug
therapy or have failed such treatment.
Victrelis, a protease inhibitor, which work by binding
to the virus and preventing it from multiplying, is a pill taken three times a
day with food. The most commonly reported side effects include fatigue, anemia,
nausea, headache and dysgeusia. Source: FDA
Everolimus
Approved for the Treatment of Progressive Neuroendocrine Tumors of Pancreatic Origin. 5/05/2011. The FDA has
approved the use of everolimus for the treatment of progressive neuroendocrine
tumors of pancreatic origin in patients with unresectable, locally advanced or
metastatic disease. The safety and effectiveness of everolimus in the treatment
of patients with carcinoid tumors have not been established. The recommended
dose and schedule for everolimus is 10 mg orally each day. The most common
adverse reactions are stomatitis, rash, diarrhea, fatigue, edema, abdominal
pain, nausea, fever, and headache. Source: FDA
Benzocaine Associated with Methemoglobinemia. 4/07/2011.
The FDA is warning consumers that the use of benzocaine, the main ingredient in
OTC gels, liquids, lozenges, and spray solutions applied to the gums or mouth
to reduce pain, including Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and
store brands, has been found to be associated with methemoglobinemia, a rare,
serious condition in which the amount of oxygen carried through the blood
stream becomes greatly reduced and can in severe cases result in death. If the
symptoms including pale, gray or blue colored skin, lips, and nail beds,
shortness of breath, fatigue, confusion, headache, lightheadedness, and rapid
heart rate are observed after taking benzocaine, seek medical attention
immediately. Source: FDA
Tradjenta
(linagliptin)
Approved to Improve Glucose Control in Patients with Type 2
Diabetes. 5/02/2011.
The FDA has approved Tradjenta (linagliptin) tablets to improve blood
glucose
control in adults with Type 2 diabetes by increasing the level of
hormones
that stimulate the release of insulin after a meal by blocking the
enzyme
dipeptidyl peptidase-4 or DPP-4.
The
most common side effects of Tradjenta are upper
respiratory
infection, stuffy or runny nose, sore throat, muscle pain, and
headache.
Tradjenta has not been studied in combination with insulin, and
should
not be used to treat people with Type 1 diabetes or in those who have
diabetic
ketoacidosis. Source: FDA
April
2011
Abiraterone
Acetate Approved for Treatment of Patients with Metastatic Castration-Resistant
Prostate Cancer. 4/28/2011. The FDA has approved abiraterone acetate (Zytiga Tablets, Centocor Ortho
Biotech, Inc.) for use in combination with prednisone for the treatment of
patients with metastatic castration-resistant prostate cancer (mCRPC) who have
received prior chemotherapy containing docetaxel at a recommended dose of
abiraterone acetate at 1000 mg orally once daily in combination with prednisone
5 mg orally twice daily. The most common adverse reactions were joint swelling or
discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary
tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia,
dyspepsia and upper respiratory tract infection, and the most common
electrolyte imbalances were hypokalemia and hypophosphatemia. Source: FDA
Vandetanib
Approved to Treat Patients with Metastatic Medullary Thyroid Cancer. 4/16/2011. The FDA has approved vandetanib to treat adult patients with metastatic medullary
thyroid cancer with a Risk Evaluation and Mitigation Strategy (REMS) as
vandetanib was shown to affect the electrical activity of the heart. Vandetanib is administered
orally on a daily basis and targets medullary thyroid cancer's ability to grow
and expand. Common side effects include diarrhea, rash, nausea, high blood
pressure, headache, fatigue, decreased appetite, and stomach (abdominal) pain,
while some serious side effects include breathing complications, heart failure,
and sepsis. Source: FDA
Horizant Approved
for Restless Leg Syndrome. 4/07/2011. The FDA has approved Horizant Extended Release Tablets (gabapentin
enacarbil), a once-daily treatment for moderate-to-severe restless legs
syndrome (RLS). Horizant may cause drowsiness and dizziness and can impair a person's
ability to drive or operate complex machinery and may cause suicidal thoughts
and actions in a small number of people. Source: FDA
Updates on Drug Shortages. 4/28/2011. Acetylcysteine
inhalation solution, Cytarabine injection (powder for reconstitution), Daunorubicin
hydrochloride solution for injection, Digoxin Injection, Diltiazem Injection,
Fentanyl Transdermal System, Lorazepam Injection, Methylphenidate HCl, MVI injectable (Adult
and pediatric), Neostigmine methylsulfate injection, Phenylephrine HCl
Injection, Propofol Injection, Thiotepa for Injection, Bedford 15
mg/mL vial (NDC 55390-0030-10). Source: FDA
Generic Drug Approvals by the FDA. 4/28/2011. Adderall XR
Capsules, Amlodipine Besylate Tablets, Amphetamine Mixed Salts, ER
Capsules, Calcium Acetate Tablets, Children's Cetirizine Hydrochloride (cetirizine hydrochloride) Oral Solution, Cyclobenzaprine Hydrochloride Extended-Release Capsules, Cytarabine
injection, Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets, Divalproex Sodium Delayed-Release Tablets, Duexis (ibuprofen and
famotidine) Tablets, Epirubicin Hydrochloride Injection, Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, Imiquimod Cream, Indomethacin
Capsules, Lamotrigine
Tablets, Lotemax (loteprednol
etabonate) Ophthalmic Ointment, Nafcillin
Injection, Paroxetine Hydrochloride Extended-Release Tablets, Naratriptan
Tablets, Phoslyra
(calcium acetate) Oral Solution, Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Risperidone
Orally-Disintegrating Tablets, Theophylline Oral
Solution, Venlafaxine Hydrochloride Extended-Release Capsules, Zytiga (abiraterone
acetate) Tablets. Source: FDA
Topiramate
(Topamax) Recall. 4/15/2011. Ortho-McNeil
Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling
two lots of Topamax (topiramate) 100mg Tablets due to the presence of TBA
(2,4,6 tribromoanisole), which is not toxic but generates a musty odor and has
been reported to be associated with temporary gastrointestinal symptoms. Source: FDA
Acterma
Approved for Treatment of Active Systemic
Juvenile Idiopathic Arthritis (SJIA). 4/15/2011. The FDA has approved Actemra (tocilizumab), given alone or in combination
with methotrexate, for the treatment of active systemic juvenile idiopathic
arthritis (SJIA), a rare, potentially life-threatening disorder in children
that causes severe inflammation throughout the body, in children ages 2 years
and older. In an international, multicenter controlled trial, eighty-five
percent of those receiving Actemra responded to treatment, compared with 24
percent of patients receiving placebo, and the most common side-effects included upper respiratory
tract infection, headache, sore throat, and diarrhea. Source: FDA
Rituxan
(rituximab) Approved to Treat Wegener's Granulomatosis and Microscopic
Polyangiitis. 4/19/2011. The FDA has approved Rituxan (rituximab), in combination with glucocorticoids
(steroids), as the first approved treatment for Wegener's granulomatosis (WG)
and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel
inflammation (vasculitis). Rituxan carries a Boxed Warning for infusion reactions, rashes
and sores in the skin and mouth, and progressive multifocal
leukoencephalopathy, a brain infection that generally is fatal. The most common
side effects in study participants with WG and MPA included infection, nausea,
diarrhea, headache, muscle spasms, and anemia. The safety and efficacy of
retreatment with subsequent courses of Rituxan has not been established. Source: FDA
Hepatosplenic
T-Cell Lymphoma in Adolescents and Young Adults Receiving Tumor Necrosis Factor
Blockers, Azathioprine and Mercaptopurine. 4/14/2011. The FDA is warning the public and healthcare
providers of reports of a rare cancer known as
Hepatosplenic T-Cell Lymphoma or HSTCL in adolescents and young adults being
treated with medicines known as tumor necrosis factor (TNF) blockers, as well
as with azathioprine, and/or mercaptopurine. Although most reported cases of
HSTCL occurred in patients treated with a combination of medicines known to
suppress the immune system, including the TNF blockers, azathioprine, and
mercaptopurine, there have been cases reported in patients receiving
azathioprine or mercaptopurine alone. The risks and benefits of using TNF
blockers, azathioprine, and mercaptopurine should be carefully weighed before
prescribing these drugs to children and young adults, especially for the treatment
of Crohn's disease and ulcerative colitis. Source: FDA
Safety Review
Update of Olmesartan (Benicar). 4/14/2011. After reviewing the results of trials
concerning olmesartan's (Benicar) association with
cardiovascular events, the FDA has determined that the benefits of olmesartan (Benicar) continue to
outweigh its potential risks when used for the treatment of patients with high
blood pressure according to the drug label. Source: FDA
Pradaxa Storage and Handling Requirements. 3/03/2011. Pradaxa
(dabigatran etexilate mesylate) capsules have a strong
potential to breakdown from moisture and loss of potency, and should therefore
only be dispensed and stored in the original bottle or blister package.
Pharmacists should only dispense Pradaxa in the original manufacturer bottle
with the original dessicant cap, rather than repackage in the standard amber
pharmacy vials. Patients should
open only one bottle at a time, using the product within 30 days, and storing
in original bottle rather than pill boxes or pill organizers. Source: FDA
Meds IV
Pharmacy IV Compounded Products Recalled. 3/03/2011. Nineteen cases of Serratia marcescens bacteremia have been identified in six
Alabama hopitals with a potential common source of TPN (total parenatal
nutrition) produced by Meds IV.
The investigation is ongoing, but in the meantime Meds IV has recalled all of
its IV compounded products. Source: FDA
Peginterferon alfa-2b
Approved for Melanoma. 3/29/2011. The FDA has approved peginterferon alfa-2b (Sylatron, Schering Corporation,
Kenilworth, NJ 07033), for the treatment of patients with melanoma with
microscopic or gross nodal involvement within 84 days of definitive surgical
resection including complete lymphadenectomy. The recommended dose and schedule for
Sylatron is 6 mcg/kg/week, subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously, with the most common
adverse reactions being fatigue, increased ALT, increased AST, pyrexia,
headache, anorexia, myalgia, nausea, chills, and injection site reactions. Source: FDA
Irinotecan
Hydrochloride Injection Recall. 3/28/2011. APP
Pharmaceuticals, Inc. issued a voluntary recall of five lots of Irinotecan
Hydrochloride Injection due to fungal microbial particulate and non-sterility,
which could result in fatal infections, especially in immunocompromised
patients. See press release for
recalled lot numbers. Source: FDA
Citalopram And Finasteride Recall. 3/28/2011. Greenstone LLC has issued a recall of all
medicines with lot number FI0510058-A due to
possible mislabeling. Bottles labeled as
Citalopram (used to treat depression) may contain Finasteride (used for the
treatment of benign prostatic hyperplasia). Finasteride
should not be used or handled by pregnant women, and the abrupt discontinuation
of Citalopram may cause discontuation symptoms an worsening of depression. Source: FDA
March 2011
Updates on Drug Shortages.3/25/2011. Amikacin Injection, Avalide
(irbesartan and hydrochlorothiazide) Tablets, Bumetanide Injection, Calcium
Gluconate, Cytarabine
injection, Dexamethasone Injection, Doxorubicin Solution for Injection,
Fabrazyme (agalsidase beta), Heparin Sodium in 5% Dextrose premix product,
Levoleucovorin (Fusilev) 50 mg single use vials, Nalbuphine Injection,
Neostigmine methylsulfate injection, Nitroglycerin in Dextrose 5%, Norepinephrine Bitartrate Injection, Opana ER strengths 7.5 mg and 15 mg, Procainamide HCL Injection,
100mg/ml (NDC# 00409-1902-01) 500mg/ml (NDC# 00409-1903-01), Sodium Chloride
23.4%, Sodium Chloride 14.6% Injection, Xeloda 500 Tablets. Source: FDA
Generic Drug Approvals by the FDA.3/25/2011. Allopurinol Tablets, Aztreonam
Injection, Benlysta (belimumab) Injection, Bicalutamide
Tablets, Briellyn (Norethindrone and Ethinyl Estradiol) Tablets, Calcipotriene Topical Solution, Desoximetasone Gel, Epinastine
Hydrochloride Ophthalmic Solution, Famciclovir
Tablets, Gadavist (gadobutrol) Injection, Latanoprost
Ophthalmic Solution, Lidocaine Hydrochloride Jelly, Naproxen Sodium Tablets, Norgestimate and Ethinyl Estradiol Tablets, Oxycodone and Aspirin Tablets, Propranolol Hydrochloride Extended-Release Capsules, Ranitidine Oral Solution, Topotecan Hydrochloride Injection, Torsemide
Tablets, Valacyclovir
Hydrochloride Tablets, Zyclara (imiquimod)
Topical Cream. Source: FDA
Proton Pump
Inhibitors and Fracture Risk Update.3/23/2011. The FDA has determined that fracture risk is
unlikely with the use of OTC proton pump inhibitors (PPI) in a short-term
manner as directed. Healthcare professionals should be aware of the risk for
fracture associated with higher dose prescription PPIs and the long-term use of
OTC PPIs. Source: FDA
American Regent
Injectables Recall Expanded.3/18/2011. Dexamethasone
Sodium Phosphate Injection products and Concentrated Sodium Chloride Injection
products have been added to the recall issued for American Regent Injectable
products due to the presence of translucent visible
particles consistent with glass delamination in some vials. Source: FDA
Povidine Iodine
Prep Pads Recall. 3/18/2011. H&P
industries, Inc. issued a voluntary recall of all lots of Providine Iodine Prep
Pads when testing showed the presence of Elizabethkingia meningoseptica, which
could cause life-threatening infections.
This recall includes products under the brand
names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North
Safety, and Total Resources. Source: FDA
Primatene Mist
With Chlorofluorocarbons to be discontinued.3/16/2011. Primatene Mist
(epinephrine), an only over-the-counter inhaler approved by the FDA for the
temporary relief of occasional symptoms of mild asthma, will no longer be
available next year as part of an international agreement to stop the use of
substances that damage the environment, because they use chlorofluorocarbons
(CFCs), which harm the environment by decreasing the earth's ozone layer. FDA urges those who use
Primatene Mist to see a health care professional soon to switch to another
asthma medicine. Source: FDA
Gadavist
Approved as Imaging Agent for Central Nervous System MRIs.3/15/2011. The FDA has approved Gadavist (gadobutrol), a gadolinium-based contrast agent (GBCA),
for use in patients undergoing magnetic resonance imaging (MRI) of the central
nervous system. The use of
Gadavist has improved the visualization of lesions found in MRIs, and poses a
lower risk of nephrogenic systemic fibrosis than other GBCAs. Source: FDA
Benlysta Approved to Treat Lupus. 3/09/2011. The FDA has approved Benlysta (belimumab), a first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. The most common side effects observed in the studies included nausea, diarrhea, and fever. Source: FDA
Increased risk of health problems in premature babies given Kaletra (lopinavir/ritonavir) oral solution.
Liver injury warning to be removed from Letairis (ambrisentan) tablets.
Topiramate May Cause Cleft Lip/Palate in Infants When Used by Pregnant Women. 3/04/2011. The FDA is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate in infants born to pregnant women treated with topiramate, an anticonvulsant medication used to treat epilepsy and prevent migraines. Source: FDA
Roflumilast Approved to Treat Chronic Obstructive Pulmonary Disease. 3/01/2011. The FDA has approved the use of roflumilast, an inhibitor of an enzyme called phosphodiesterase type 4, to decrease the frequency of flare-ups from severe chronic obstructive pulmonary disease (COPD), a serious lung disease with symptoms such as breathlessness, chronic cough and excessive phlegm. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness. Source: FDA
Prolonged Use of Proton Pump Inhibitors May Cause Hypomagnesemia. 3/02/2011. The FDA is alerting the public that prolonged use of proton pump inhibitors, including Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), and AcipHex (rabeprazole sodium), used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus, may cause low serum magnesium levels (hypomagnesemia). Low serum magnesium levels can but do not always result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels. Source: FDA
February 2011
Edarbi Approved to treat High Blood Pressure. 2/25/2011. The FDA has approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure in adults and it will be available in 80 milligram and 40 mg doses. Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone and should not be used in pregnant women during the second or third trimester as it can can cause injury and even death in the developing fetus. Source: FDA
Extenze Tablets: Recall.
Antipsychotic Drugs Used in Pregnant Women May Affect Newborns. 2/22/2011. The FDA is informing healthcare professionals that the use of antipsychotic drugs in pregnant women during the third trimester may cause abnormal muscle movements, symptoms of EPS and withdrawal in newborns, including agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. The Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated to include this information. Source: FDA
Warfarin Sodium Tablets (Jantoven), 3mg Recall. 2/21/2011. Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of a lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, after a single bottle was found to contain tablets at a higher 10mg strength, which would risk overdosing more than 3 times the labeled amount leading to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients. The affected Jantoven Warfarin Sodium lot is numbered as #284081, with an expiration date of September 2012 and the recall has been expanded to include the products Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven and Oxybutynin. Source: FDA
Terbutaline Not Safe for Use in Pregnant Women for Treatment or Prevention of Preterm Labor. 2/17/2011. The FDA has notified health care professionals that Terbutaline, approved to prevent and treat bronchospasm associated with asthma, bronchitis, and emphysema, and used in an off-label manner for acute obstetric uses, should not be used in pregnant women to treat or prevent preterm labor, because of the risk of serious maternal heart failure and death. The FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warning about these risks. Source: FDA
U.S. Marshals seize Auralgan Otic Solution. 2/16/2011. After issuing a Warning Letter to Deston Therapeutics that sale of Auralgan Otic Solution, used to treat pain associated with ear infections, in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use, the FDA had US Marshals sieze all lots of the drug from the warehouse at Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky. Source: FDA
Updates on Drug Shortages. 2/17/2011. Amino Acid Injection, Ammonium chloride injection, 5 mEq/mL, 20 mL vial (NDC 00409-6043-01), Bumetanide Injection, Cytarabine injection (powder for reconstitution), Desmopressin injection, Doxorubicin (adriamycin) lyophilized powder, Doxorubicin Solution for Injection, Ephedrine Sulfate Injection 50mg/ml (NDC 00409-3073-31), Etoposide solution for injection, Fabrazyme (agalsidase beta), Fosphenytoin Sodium Injection, Haloperidol Decanoate Injection, Leucovorin Calcium Lyophilized Powder for Injection, Mebaral (mephobarbital) 32mg tablets, 50mg tablets and 100mg tablets, Metoclopramide injection, Morphine Injection, Nalbuphine Injection, Nitroglycerin Solution 5mg/ml 10ml (NDC 00517-4810-25), Nitroglycerin in Dextrose 5%, Norepinephrine Bitartrate Injection, Procainamide HCL Injection, 100mg/ml (NDC# 00409-1902-01) 500mg/ml (NDC# 00409-1903-01), Regonol injection, 5 mg/mL, 2 mL ampules (NDC 00781-3040-95), Renacidin Irrigation NDC# 00327-0011-05, Sodium Chloride 14.6% Injection, Sodium Chloride 23.4%, Sinemet (carbidopa-levodopa) 25 mg/100 mg tablets, Succinylcholine injection, Vecuronium Injection. Source: FDA
Generic Drug Approvals by the FDA. 2/16/2011. Clonidine Hydrochloride Injection, Fentanyl Transdermal System, Gabapentin Tablets, Glipizide and Metformin Hydrochloride Tablets, Galantamine Hydrobromide Extended-Release capsules, Gralise (gabapentin) Tablets, Ibuprofen Tablets, Levetiracetam Tablets, Levofloxacin Ophthalmic Solution, Lithium Carbonate Extended-Release Tablets, Makena (hydroxyprogesterone caproate) Injection, Mirtazapine Orally Disintegrating, Naproxen Tablets, Naratriptan Tablets, Nisoldipine Extended-Release Tablets, Octreotide Acetate Injection, Omeprazole Delayed-Release Capsules, Clarithromycin Tablets and Amoxicillin Capsules, Ondansetron Hydrochloride Oral Solution, Phentermine Hydrochloride Tablets, Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Risperidone Oral Solution, Tolterodine Tartrate Tablets, Topotecan Hydrochloride Injection, Tramadol Hydrochloride Tablets.Source: FDA
Rosiglitazone (Avandia) Labels Updated Regarding Cardiovascular Risk. 2/03/2011. Information on the cardiovascular risks of the diabetes drug rosiglitazone, sold as Avandia, Avandamet, and Avandaryl, has been added to the physician labeling and patient Medication Guide. The updated labels also state that rosiglitazone-containing medicines should only be used in patients already being treated with these medicines, whose blood sugar cannot be controlled with other anti-diabetic medicines, and who do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact). Source:FDA
American Regent Injectable Products Recall. 2/05/2011. A recall was initiated for American Regent injectable products because some vials exhibit translucent visible particles consistent with glass delamination, which can cause damage to blood vessels in the lung, localized swelling, and granuloma formation. Source:FDA
Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets Recall.2/07/2011. Qualitest has issued a recall for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A because an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. If patients unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, respiratory depression, CNS depression, coma and death, liver toxicity and/or loss of seizure control may occur. Source:FDA
January 2011
Updates on Drug Shortages. 1/25/2011. Amikacin Injection, BICNU (carmustine) Injection, Bleomycin Injection, Cerezyme (imiglucerase) Injection, Chloroquine Phosphate Tablets, Cytarabine injection (powder for reconstitution), Faslodex (fulvestrant) Injection: one 5.0 ml syringe (250mg/5ml), NDC 0310-0720-50, Galantamine Hydrobromide Extended-Release Capsules, Hydrocodone Bitartrate and Acetaminophen Tablets, Intravenous Fat Emulsion, Pentothal (thiopental) Injection, Tamiflu for Oral Suspension 12mg/ml 25 ml (NDC 00004-0810-95). Source: FDA
Generic Drug Approvals by the FDA. 1/25/2011. Acarbose Tablets, Anastrozole Tablets, Atovaquone and Proguanil Hydrochloride Tablets, Clobex (clobetasol propionate) Spray, Chloroquine Phosphate Tablets, DaTscan (ioflupane I 123) Injection, Fortesta (testosterone) Gel, Losartan Potassium and Hydrochlorothiazide Tablets, Metronidazole Gel, Nabumetone Tablets, Nithiodote (sodium nitrite and sodium thiosulfate) Injection, Pantoprazole Sodium Delayed-Release Tablets, Viibryd (vilazodone hydrochloride) Tablets. Source: FDA
Metronidazole Tablets Recall. 1/06/2011. Metronidazole Tablets USP, 250mg, lot #312566, expiration date 05/2012, indicated for the treatment of symptomatic and asymptomatic trichomoniasis, and treatment of asymptomatic consorts, amebiasis and a variety of anaerobic bacterial infections, is being recalled due to the presence of underweight tablets, which may not contain the full amount of active ingredient, causing the infection that the drug was intended to treat to worsen or recur. Source: FDA
Acetaminophen Limited to 325mg. 1/13/2011. In order to reduce the risk of severe liver damage and allergic reactions, the FDA has asked drug manufacturers to limit the strength of acetaminophen to 325mg per tablet, capsule, or other dosage unit. A boxed warning highlighting the potential for severe liver damage and allergic reactions, such as swelling of the face, mouth, and throat, difficulty breathing, or rash, will be added to all prescription drugs containing acetaminophen. Source: FDA
Fentanyl (Abstral) Approved for Pain Management in Cancer Patients. 1/07/2011. Fentanyl (Abstral) transmucosal tablets have been approved by the FDA as part of an REMS program for use in breakthrough pain management for cancer patients 18 years and older. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth or the nasal passages or throat, and common adverse reactions include nausea, constipation, drowsiness and headache. Source: FDA
Morphine Sulfate Oral Solution Dosing Errors. 1/10/2011. The FDA is notifying healthcare professional that Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL), indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients, can cause serious adverse events and death when interchanging milliliters for milligrams. New product labeling and packaging feature revisions have been approved intending to reduce the risk of such medication errors. Source: FDA
Severe Liver Injury Associated with Dronedarone (Multaq). 1/14/2011. The FDA is alerting healthcare professionals and patients that Dronedarone (Multaq), used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm in the past 6 months, has resulted in rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant. Information about the potential risk of liver injury is being added to dronedarone labels. Source: FDA
Spinosad (Natroba) Approved for Head Lice Treatment. 1/18/2011. The FDA has approved spinosad marketed as Natroba Topical Suspension 0.9% for the treatment of head lice infestation in patients 4 years and older. Common adverse events include redness or irritation of the eyes and skin. This product should not be used in infants because it contains benzyl alcohol. Source: FDA
Generic Drug Approvals by the FDA. 1/05/2011. Cephalexin Capsules, Ciclopirox Cream, Doxycycline Hyclate Delayed-Release Tablets, Felodipine Extended-Release Tablets, Gabapentin Capsules, Hydralazine Hydrochloride Tablets, Ibuprofen Tablets, Irinotecan Hydrochloride Injection, Levetiracetam Tablets, Levofloxacin Ophthalmic Solution, Lidocaine Hydrochloride Injection, Lithium Carbonate Tablets, Lithium Carbonate Extended-Release Tablets, Oxymorphone Hydrochloride Extended-Release Tablets, Phenelzine Sulfate Tablets, Promethazine Hydrochloride Tablets, Ranitidine Hydrochloride Syrup, Rhinocort (budesonide) Nasal Spray, Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets, Silarx Pharmaceuticals, Venlafaxine Hydrochloride Tablets. Source: FDA
Updates on Drug Shortages. 1/05/2011. Amikacin Injection, Avalide (irbesartan and hydrochlorothiazide) Tablets, Bleomycin Injection, Cytarabine injection (powder for reconstitution), Doxorubicin (adriamycin) lyophilized powder, Ethiodol (ETHIODIZED OIL) ampules, Erythromycin lactobionate injection, Furosemide Injection 10mg/ml, Haloperidol Decanoate Injection, Leucovorin Calcium Lyophilized Powder for Injection, Pancuronium Injection, Pontocaine HCL Injection products, Procainamide HCL Injection, Vecuronium Injection. Source: FDA
Unsafe Sexual Enhancement Drugs. The FDA has identified a trend of the presence of hidden, potentially harmful active ingredients in otc drugs represented as dietary supplements for sexual enhancement. The FDA warns against the use of the following drugs for this reason: Rock Hard Extreme, Passion Coffee, Man Up Now capsules, Vigor-25, TimeOut Capsules, Magic Power Cofee, Stiff Nights, RockHard Weekend, Xiadafil VIP Tablets, Pandora, Duro Extend Capsules for Men, Mr. Magic Male Enhancer, Protalis, Revivexxx Extra Strength, ejaculoid XXTEME, stimuloid II, Vialipro, Zencore Plus, Stud Capsule for Men, Libipower Plus, Stamina-Rx, Rize 2 The Occasion Capsules, Rose 4 Her Capsules, Viril-Ity-Power (VIP) Tabs, Maxidus pills, Aspire36, Aspire Lite, Encore Tabs, True Man's Sexual Energy Nutriment Men's Formula, Energy Max, Viapro 375 mg Capsules, and more. Source: FDA
December 2010
Dexamethasone Sodium Phosphate Injection Recall. 12/24/2011. A voluntary recall has been issued for specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30mL Multiple Dose Vial because some of these lots wither contain particulates or have the potential to fom particulates prior to their expiration dates. Affected lot numbers and expiration dates: 8811, 12/2010; 9093, 02/2011; 9195, 03/2011; 9296, 04/2011; 9419 06/2011; 9505, 07/2011; 9649, 09/2011. Source: FDA
Sodium Bicarbonate Injections Recall. 12/29/2011. A voluntary recall has been issued for Sodium Bicarbonate Injections USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial NDC # 0517-0639-25 and 8.4%, 50 mEq/50 mL, Single Dose Vial NDC # 0517-1550-25, because some vials contain particulates which may cause damage to blood vessels in the lung, localized swelling, and granuloma formation. Source: FDA
Dolasetron Mesylate (Anzemet) Can Cause Abnormal Heart Rhythms. 12/17/2010. The FDA is informing patients and healthcare providers that the injection form of dolasetron mesylate (Anzemet) can increase the risk of developing torsade de pointes (abnormal heart rhythm), which in some cases can be fatal, and should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy. Source: FDA
Generic Drug Approvals by the FDA. 12/08/2010. Axiron (testosterone) Topical Solution, Ciprofloxacin Extended Release (ciprofloxin and ciprofloxin hydrochloride) Extended-Release Tablets, Crestor (rosuvastatin calcium) Tablets, Gablofen (baclofen) Injection, Hydrochlorothiazide Capsules,Ibuprofen and Diphenhydramine Capsule, Indomethacin Extended-Release Capsules, Levocetirizine Dihydrochloride Tablets, Mefenamic Acid Capsules, Midazolam Hydrochloride Injection, Moxeza (moxifloxacin hydrochloride) Ophthalmic Solution, Pramipexole Dihydrochloride Tablets, Topotecan Hydrochloride Injection, Zafirlukast Tablets. Source: FDA
Updates on Drug Shortages. 12/08/2010. Aquasol A, 50,000 units/mL, 2 mL ampule (NDC 61703-418-07), Arginine 10% injection (R-Gene 10), Desmopressin injection, Doxorubicin Solution for Injection, Levorphanol 2mg Tablets. Source: FDA
November 2010
Generic Drug Approvals by the FDA. 11/12/2010. Cyclafem 1/35 (norethindrone and ethinyl estradiol) Tablets, Cyclafem 7/7/7 (norethindrone and ethinyl estradiol) Tablets, Cymbalta (duloxetine hydrochloride) Capsules, Desloratadine Tablets, Diltiazem Hydrochloride Extended-Release Capsules, Duac (benzoyl peroxide and clindamycin) Gel, Egrifta (tesamorelin) Injection, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Gemcitabine Injection, Halaven (eribulin mesylate) Injection, Indomethacin Capsules, Kombiglyze (saxagliptin and metformin hydrochloride) Extended-Release Tablets, Lamotrigine Tablets, Levetiracetam Tablets, Metformin Hydrochloride Tablets, Ofirmev (acetaminophen) injection, Prednisone Tablets, Ranitidine Hydrochloride (Zantac) Syrup, Trihexyphenidyl Hydrochloride Tablets, Trospium Chloride Tablets. Source: FDA
Updates on Drug Shortages. 11/19/2010. Amino Acid Injection, Arginine 10% injection (R-Gene 10), Bumetanide Injection, Desmopressin injection, Doxorubicin (Adriamycin) lyophilized powder, Doxorubicin Solution for Injection, Erythromycin lactobionate injection, Fosphenytoin Sodium Injection, GlucaGen 1mg Hypokit, Humalog Mix 75/25 and Humalog Mix 50/50 (original prefilled pen), Leucovorin Calcium Lyophilized Powder for Injection, Levorphanol 2mg Tablets, Mitomycin for injection, Nalbuphine Injection, Naloxone Injection, Pancuronium Injection, Procainamide HCL Injection, Tromethamine 500 mL Injection, NDC 0409-1593-04, Thyrogen (thyrotropin alfa) injection 1.1 mg/vial, Vecuronium Injection. Source: FDA
Withdrawl of Propoxyphene-Containing Products. 11/19/2010. Propoxyphene, an opioid medication approved in 1957 for pain relief, has been under study to evaluate its safety and therefore the appropriateness of its availability. Propoxyphene products are now being withdrawn from the market due to these recent trial results, which that even when propoxyphene was taken at recommended doses, there were significant changes to the electrical activity of the heart, including prolonged PR interval, widened QRS complex and prolonged QT interval. Source: FDA
Eribulin Mesylate (Halaven) Approved to Treat Breast Cancer. 11/15/2010. The injectable microtubule inhibitor eribulin mesylate (Halaven), a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai, has been approved by the FDA to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. The most commonly reported side effects include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation. Source: FDA
Tesamorelin (Egrifta) Approved to Treat HIV-Lipodystrophy. 11/10/2010. Tesamorelin (Egrifta), a growth hormone releasing factor (GRF) drug administered in a once-daily injection, has been approved by the FDA to treat HIV patients with lipodystrophy, a condition associated with many antiretroviral drugs. The most common side effects reported during trials include joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia), as well as an increased occurrence of worsening blood sugar control. Source: FDA
Fentanyl Transdermal System Recall. 11/05/2010. Fentanyl Transdermal System, indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, has been recalled after laboratory testing identified a patch that released the active ingredient faster than the approved specification. Accelerated release of Fentanyl can lead to excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea. Recalled lot numbers can be found in the press release. Source: FDA
October 2010.
Generic Drug Approvals by the FDA. 10/21/2010. Amlodipine Besylate and Benazepril Hydrochloride Capsules, Aridol (mannitol) Inhalation Powder, Atomoxetine Hydrochloride Capsules, Enablex (darifenacin) Extended-Release Tablets, H.P. Acthar Gel (repository corticotropin) Injection, Lansoprazole Delayed-release Capsules, Lansoprazole Delayed-Release Orally Disintegrating Tablets, Levetiracetam Oral Solution, Levetiracetam Tablets, Losartan Potassium Tablets, Losartan Potassium and Hydrochlorothiazide Tablets, PRADAXA (dabigatran etexilate mesylate) Capsules, Pramipexole Dihydrochloride Tablets, Propafenone Hydrochloride Extended-Release Capsules,Sorilux (calcipotriene) Foam, Zolpidem Tartrate Extended-Release Tablets. Source: FDA
Updates on Drug Shortages. 10/21/2010. Adriamycin (doxorubicin) lyophilized powder, Amino Acid Injection, Aminophylline, Bumetanide Injection, Etoposide solution for injection, Glucagon 1mg emergency kit, GlucaGen 1mg Hypokit and GlucaGen 1mg Vials, Humulin 50/50 Insulin, Mitomycin for injection, Morphine Injection, Nalbuphine Injection, Succinylcholine injection. Source: FDA
Clonidine Hydrochloride Extended Release (Kapvay) Approved as New Non-Stimulant ADHA Medication. 10/20/2010. Clonidine hydrochloride extended release (Kapvay) has been approved by the FDA for use in treating attention-deficit/hyperactivity disorder (ADHA) in patients ages 6-17 years as monotherapy or for adjunctive use with stimulant medication. Clonidine hydrochloride extended release (Kapvya) twice-daily oral non-stimulant tablets work as centrally acting alpha2-adrenergic receptor agonists, which have demonstrated efficacy in two phase III studies and is anticipated to be commercially available in January 2011. Source: AAP
Methotrexate Injection Recall. 10/29/2010. Certain lots of Methotrexate Injection 50mg/2mL and 250mg/10mL vials, used to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis, have been recalled due to the presence of glass flakes. Patients should immediately discontinue use of the recalled products whose lot numbers, label type, expiration dates, and recall instructions are listed in the Press Release. Source: FDA
Hyland's Teething Tablets Recalled. 10/23/2010. Hyland's Teething Tablets have been recalled due to the risk of belladonna toxicity resulting from inconsistent amounts of the drug found in these tablets. Consumers should consult their health care provider if their child experiences symptoms of belladonna toxicity, including seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation, after using Hyland's Teething Tablets. Source: FDA
New Warnings for Class of Prostate Cancer Drugs. 10/20/2010. Due to data suggesting an increased risk for diabetes, heart attack, stroke, and sudden death, the FDA is asking manufacturers to add new warning labels to gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat prostate cancer by suppressing the production of testosterone. Source: FDA
Dabigatran Etexilate (Pradaxa) Approved to Prevent Clots in Atrial Fibrillation Patients. 10/19/2010. The FDA approved dabigatran etexilate (Pradaxa) to prevent blood clots and thus stroke in patients with atrial fibrillation. Dabigatran etexilate (Pradaxa) is an anticoagulant that acts by inhibiting thrombin, and common adverse effects include excessive bleeding and gastrointestinal symptoms. Source: FDA
Tylenol Recall. 10/19/2010. McNeil is issuing a voluntary recall of Tylenol 8 Hour caplets 50 count bottles due to reports of a musty, moldy odor, thought to indicate the presence of the chemical 2,4,6-tribromoanisole. Although the risk of adverse medical events is remote, consumers should stop using the effected product. Source: FDA
Botox for Chronic Migraines. 10/15/2010. The FDA approved the use of Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine, defined as a history of migraine and headaches more than 14 days of the month. Botox injections are given every 12 weeks around the head and neck to treat chronic migraines, and the most common adverse reactions are neck pain and headaches. Source: FDA
FDA Warns Against Unapproved Chelation Products. 10/14/2010. The FDA warned several companies against continuing to sell their over the counter (OTC) chelation products, which claim to treat a range of diseases by removing toxic metals from the body. There are no FDA-approved OTC chelation products, making these companies in violation of federal law. Chelation products can alter the levels of certain substances in the blood and cause serious harm, including dehydration, kidney failure, and death. Source: FDA
Update Regarding Atypical Fractures Associated with Osteoporosis Bisphosphonates. 10/13/2010. Atypical femur fractures, although predominantly reported with bisphosphonate use, is not necessarily caused by it. However, the optimal duration of bisphosphonate use is unknown and long-term use may contribute to these fractures. The FDA will be including a new Limitations of Use statement and Medication Guide with bisphosphonate prescriptions to inform patients of the symptoms and risk associated with these atypical femur fractures. Source: FDA
Vivitrol Approved to Treat Opioid Dependence. 10/12/2010. The FDA has approved the use of Vivitrol, an extended-release formulation of naltrexone administered monthly by intramuscular injection, to treat and prevent relapse of opioid dependence after completing detoxification treatment. This drug blocks opioid receptors in the brain blocking the effect of opioids, which may result in withdrawl symptoms if the patients are still have opioids in their systems or sensitivity to opioids if taken at the time of the next scheduled dose; if a dose is missed or treatment has ended, opioid use can result in overdose. Side effects of Vivitrol use include nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps, reactions at the site of the injection, which can be severe and may require surgical intervention, liver damage, allergic reactions such as hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior. Source: FDA
Voluntary Sibutramine (Meridia) Recall in United States. 10/08/2010. Sibutramine (Meridia) was approved for weight-loss in obese patients with cardiovascular risk in 1997 and has been under review for a potentially serious effect on the heart. The FDA is now recommending against continued prescribing and use of sibutramine (Meridia) due to clinical trial results confirming a 16% increase in risk of major adverse cardiovascular events associated with this drug. The manufacturer of Meridia, Abbott Laboratories, has agreed to voluntarily withdraw and discontinue marketing of this drug product from the United States market. Source: FDA
Updates on Drug Shortages. 10/04/2010. Atracurium injection, Bumetanide Injection, Desmopressin injection, Dextrose 50% injection, epoetin alfa, Etoposide solution for injection, Foscarnet sodium 24 mg/mL injection, Furosemide Injection 10mg/ml, Leucovorin Calcium Lyophilized Powder for Injection, Mexiletine Capsules (150mg, 200mg, and 250mg), Mitomycin for injection, Mustargen (mechlorethamine HCl) injection, Nalbuphine Injection, Naloxone Injection, Oxycodone Immediate-Release Solution, Pancuronium Injection, Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s, Technetium Tc99m Generators, Vecuronium Injection. Source: FDA
Generic Drug Approvals by the FDA. 10/04/2010. Alprazolam Tablets, Ampicillin and Sulbactam Injection, Asmanex Twisthaler (mometasone furoate) Inhalation Powder, Atomoxetine Hydrochloride Capsules, Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets, Buprenorphine Hydrochloride Sublingual Tablets, Fludarabine Phosphate Injection, Fosinopril Sodium and Hydrochlorothiazide Tablets, Gemfibrozil Tablets, Gilenya (fingolimod) Capsules, Granisetron Hydrochloride Injection, Introvale (ethinyl estradiol and levonorgestrel) Tablets, Lidocaine Hydrochloride Preservative Free Injection, Nifedipine Extended-Release Tablets, Nizoral A-D (ketoconazole) Shampoo, Oxymorphone Hydrochloride Tablets, Prilocaine Hydrochloride Injection, Rifampin Injection, Tacrolimus Capsules. Source: FDA
September 2010
Updates on Drug Shortages. 9/19/2010. Calcium Chloride Injection, Dextrose 50% injection, Etoposide solution for injection, Humalog Contained in Original Prefilled Pen, Humalog Mix 75/25, Humalog Mix 50/50, NeoProfen (ibuprofen lysine) Injection, Technetium Tc99m Generators. Source:FDA
Generic Drug Approvals by the FDA. 9/19/2010. Atomoxetine Hydrochloride Capsules, Benzphetamine Hydrochloride Tablets, Drospirenone and Ethinyl Estradiol Tablets, Famciclovir Tablets, Imiquimod Cream, Krystexxa (pegloticase) Injection, Methylergonovine Maleate Injection, Mycophenolate Mofetil Tablets, Nifedipine Extended-Release Tablets, Prednisolone Sodium Phosphate Oral Solution, Zyrtec Allergy (cetirizine hydrochloride) Orally Disintegrating Tablets. Source: FDA
Rosiglitazone (Avandia) Restricted. 9/23/2010. The FDA is restricting Rosiglitazone (Avandia) use use to patients with Type 2 diabetes who cannot control their diabetes with other medications in response to new data which suggests an elevated risk of cardiovascular events associated with this drug. Source: FDA
FDA Approves Contraceptive Beyaz. 9/24/2010. The FDA approved the use of Beyaz, a contraceptive extremely similar to YAZ with the addition of levomefolate calcium, a metabolite of folic acid. The addition of a folate to this estrogen/progestin combination contraceptive will raise users' folate levels in order to reduce the risk of neural tube defects in the case of a pregnancy conceived during or shortly after discontinuing the use of this drug. Source: FDA
FDA Takes Action Against Marketing of Unapproved Colchicine. 9/30/2010. Colcrys is the only FDA-approved single-ingredient oral colchicine product available in the U.S. and the FDA took action against companies that manufacture, distribute, or market unapproved single-ingredient oral colchicine. These companies are expected to stop manufacturing the drug within 45 days and to stop shipping it within 90 days. Source: FDA
Epoetin Alfa (Epogen, Procrit) Recall. 9/24/2010. Certain lots of epoetin alfa (Epogen, Procrit) have been recalled because the vials may contain lamellae, barely visible flakes of glass. Information concerning affected lots is available in the firm press release. Source: FDA
First Oral Drug to Reduce Multiple Sclerosis Relapses Approved. 9/22/2010. The FDA approved the use of fingolimod (Gilenya) capsules to reduce relapses of multiple sclerosis (MS) and slow related disability progression. This is the first oral drug approved for this purpose and will offer an alternative to the current injectable therapies. The most common adverse reacions include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough. Source: FDA
New Dosing Recommendations for Valcyte (valganciclovir hydrochloride). 9/15/2010. The FDA has released new pediatric dosing recommendations for valganciclovir hydrochloride (Valcyte oral tablets and oral solution), an antiviral medication used to prevent cytomegalovirus (CMV) disease in children who have undergone a kidney or heart transplant. The update is being made to prevent potential valganciclovir overdosing in children with low body weight, body surface area, and serum creatinine. Source:FDA
Possible Increased Risk of Certain Femur Fractures with Bisphosphonates Use. 9/14/2010. The American Society of Bone and Mineral Research released a report on the association between long-term use of bisphosphonates, used to treat osteoporosis, and certain serious femur fractures. The report includes a case definition of this type of fracture, which will help in identifying, and hopefully reporting cases, facilitating future studies of this association. Healthcare professionals should be aware of this possible risk and report any cases to FDA's MedWatch program. Source:FDA
Label Changes for Gadolinium-based Contrast Agents (GBCAs). 9/09/2010. The FDA is requiring label changes for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF) when used in certain patients with kidney dysfunction. NSF can cause deadly fibrosis of the internal organs, and when receiving GBCAs, patients at risk for NSF should be actively monitored for NSF symptoms, which include red or dark patches, scaling, hardening, and tightening of the skin, and stiffness. Source: FDA
Pralidoxime Chloride (Protopam Chloride) Approved for Pediatric Use. 9/09/2010. Pralidoxime chloride (Protopam Chloride) has been approved for treatment of pesticide and chemical poisoning of children. Pralidoxime chloride has been widely used to treat pediatric patients in emergency situations, but this approval provides accurated dosing information for children and a new option of intramuscular (IM) injection, which can often be used more quickly and accurately than intravenous (IV) injection in children. Source:FDA
Updates on Drug Shortages. 9/06/2010. Atracurium injection, Calcium Chloride Injection, Cisplatin injection 1 mg/mL solution, Dextrose 50% injection, Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34), Etoposide solution for injection, Fabrazyme (agalsidase beta), Furosemide Injection 10mg/ml, Haloperidol Decanoate Injection, Leucovorin Calcium Lyophilized Powder for Injection, Mexiletine Capsules (150mg, 200mg, and 250mg), Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg), Mitomycin for injection, Succinylcholine injection, Technetium Tc99m Generators. Source: FDA
Generic Drug Approvals by the FDA. 9/06/2010. Atomoxetine Hydrochloride Capsules, Carbinoxamine Maleate Tablets, Clonidine Patch, Hydrocortisone Topical Cream, Lumigan (bimatoprost) Ophthalmic Solution, Nandrolone Decanoate Injection, Perindopril Erbumine Tablets, Phendimetrazine Tartrate Tablets, Simvastatin Tablets, Suboxone (buprenorphine and naloxone) Film Oral, Tekamlo (aliskiren and amlodipine) Tablets, Topiramate Tablets. Source: FDA
Insulin Storage and Substitution. 9/06/2010. The FDA published general guidelines concerning Insulin storage and switching, which may be particularly useful in times of emergency or disasters. Insulin should be kept from extreme temperatures as much as possible to maintain potency, and certain brands and types of Insulin may be substituted for each other. For details, see FDA.
Increased Risk of Death with Tygacil (tigecycline) Use. 9/01/2010. The FDA reminds healthcare professionals that trials have found an increased incidence of death associated with tigecycline use as opposed to treatment with similar antibiotics. Tygacil is approved for treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia, but NOT hospital-acquired pneumonia or diabetic foot infection. Source: FDA
August 2010
Updates on Drug Shortages. 8/25/2010. Calcium Chloride Injection, Cisplatin injection 1 mg/mL solution, Dextrose 50% injection, Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34), Foscarnet sodium 24 mg/mL injection, Furosemide Injection 10mg/ml, Haloperidol Decanoate Injection, Mitomycin for injection, Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg), Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s, Succinylcholine injection, Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP), Technetium Tc99m Generators, Vecuronium Injection. Source: FDA
Generic Drug Approvals by the FDA. 8/25/2010. Actos (pioglitazone hydrochloride) Tablets, Altavera (levonorgestrel and ethinyl estradiol) Tablets, Amerge (naratriptan hydrochloride) Tablets, Amlodipine Besylate and Benazepril Hydrochloride Capsules, Clotrimazole Topical Cream, Ergocalciferol Capsules, Famotidine Tablets, Isosorbide Mononitrate Extended-Release Tablets, Levetiracetam Tablets, Losartan Potassium and Hydrochlorothiazide Tablets, Ondansetron Hydrochloride Injection, Ranitidine Hydrochloride Syrup, Risperidone Orally Disintegrating Tablets, Sumatriptan Succinate Subcutaneous Injection, Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Suspension, Venlafaxine Hydrochloride Extended-Release Tablets, Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets. Source: FDA
Ongoing Safety Review of Stalevo. 8/20/2010. The addition of entacapone to carbidopa/levodopa combination drugs has lead to increased improvement in some parkinson's symptons, as seen in Stalevo use. Recent clinical trials, however, suggest an increased risk for cardiovascular events in patients taking Stalevo, as opposed to those taking Sinemet, as well. The FDA is currently investigating the issue as these trials were not designed to measure cardiovascular events and may be affected by several unrelated factors. Patients should continue Stalevo use, and healthcare professionals should regularly evaluate their cardiovascular status. Source: FDA
Proposed Withdrawl of Midodrine Hydrochloride. 8/16/2010. Midodrine hydrochloride, an orthostatic hypotension treatment, was previously approved by the FDA's accelerated approval program, which allows the use of a drug to treat serious or life-threatening conditions based on a clinical marker that predicts clinical benefits which must later be confirmed. Due to the fact that manufacturers of midodrine hydrochloride have failed to provide such confirmation, the FDA is proposing to withdraw approval of all midodrine products. Patients currently taking midodrine hydrochloride should continue use but consult their health care professionals about other possible options. Source: FDA
Ongoing Review of Unintentional Exposure to Estradiol Transdermal Spray (Evamist). 7/29/2010. The FDA is currently reviewing several reports of unintentional exposure of children and pets to estradiol transdermal spray (Evamist), a topical spray used to reduce hot flashes in menopausal women. Exposure can occur through contact with skin where drug was applied and may result in premature puberty and related symptoms, including nipple swelling, breast enlargement, and vulvar swelling. Health care professionals and/or veterinarians should be contacted if children or pets are displaying these symptoms after possible exposure. Application area should be covered if contact with the site cannot be avoided to prevent unintentional exposure. Source: FDA
Eosinophilic Pneumonia Associated with Daptomycin (Cubicin) Use. 7/29/2010. Daptomycin (Cubicin), an intravenous antibacterial drug used to treat serious skin and bloodstream infections, is associated with reports of eosinophilic pneumonia, a serious condition in which eosinophils (certain white blood cells) fill the lungs. Patients receiving daptomycin should contact their healthcare provider immediately if they experience symptoms of eosinophilic pneumonia, such as fever, cough, shortness of breath, or difficulty breathing. Source: FDA
Glycopyrrolate (Cuvposa) Approved for Chronic Drooling Reduction. 7/28/2010. Glycopyrrolate (Cuvposa), a drug used to treat peptic ulcers and minimize saliva production in patients under anesthesia, has previously been used on an off-label basis to reduce drooling in developmentally disabled patients. The FDA has approved a more-easily-administered oral solution form of this drug to treat children with neurological disorders, aged 3-16 years, and have adjusted the dosage to better suit this population. Source: FDA
Ibuprofen Lysine (NeoProfen) Injection Recall. 8/02/2010. Two lots of ibuprofen lysine (NeoProfen) Injection, a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus in premature infants, are being recalled as they have failed to meet visible particulate quality requirements. The recall, which includes lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012), will result in a temporary ibuprofen lysine shortage while the stock is being replenished by the manufacturer. Source: FDA
Nimodipine Oral Capsules NOT for Intravenous Use. 8/02/2010. The FDA is emphasizing that nimodipine capsules be administered only by mouth or feeding tube. Because instances of intravenous nimodipine use resulting in death, cardiac arrest, severe blood pressure drops, and heart-related complications, continue to be reported, the FDA is reminding healthcare providers to use more care in handling this product, such as labeling it with "Not for IV Use." Source: FDA
Aseptic Meningitis Caused by Lamotrigine (Lamictal). 8/12/2010. The FDA is announcing that the use of lamotigine (Lamictal), used to treat seizures in children and bipolar disorder in adults, can cause aseptic meningitis. Because it is important to treat meningitis rapidly, patients using lamotigine should contact their healthcare professional immediately if they experience symptoms of meningitis, which include headache, fever, chills, nauseau, vomiting, stiff neck, rash, abnormal sensitivity to light, drowsiness, and confusion. Source: FDA
ella (Ulipristal Acetate) Tablets Approved for Emergency Contraception. 8/13/2010. ella (ulipristal acetate) tablets, intended to inhibit or delay ovulation, are approved for use in preventing pregnancy when taken within five days of intercourse. This is a prescription drug, not recommended to routine use. Frequent side effects of ella, including headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness, are similar to those of other FDA approved emergency contraceptives. Source: FDA
July 2010
Updates on Drug Shortages. 7/31/2010. Amikacin injection, Atracurium injection, Calcium Chloride Injection, DDAVP Nasal Solution 0.01% Rhinal Tube, Dextrose 50% injection, Ephedrine Injection, Epinephrine, Fosphenytoin Sodium Injection, Furosemide Injection 10mg/ml, Haloperidol Decanoate Injection, Leucovorin Calcium Lyophilized Powder for Injection, Levorphanol 2mg Tablets, Mexiletine Capsules (150mg, 200mg, and 250mg), Mitomycin for injection, Naloxone Injection, NeoProfen (ibuprofen lysine) Injection, Pancuronium Injection, Technetium Tc99m Generators, Vecuronium Injection. Source: FDA
Generic Drug Approvals by the FDA. 7/31/2010. Adapalene Cream, Alsuma (sumatriptan) Injection, Aricept (donepezil hydrochloride) Tablets, Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Bupropion Hydrochloride Extended-Release Tablets, Butrans (buprenorphine) Transdermal System, Carboplatin I.V. Injection, Clindamycin Palmitate Hydrochloride Oral Solution, Clonidine Transdermal System, Cuvposa (glycopyrrolate) Oral Solution, Cyclobenzaprine Hydrochloride Tablets, Desloratadine Orally Disintegrating Tablets, Doxycycline Capsules, Enoxaparin Sodium Subcutaneous Injection, Ergocalciferol Capsules, Heparin Sodium Injection, Lastacaft (alcaftadine) Ophthalmic Solution, Levetiracetam Tablets, Megace ES (megestrol acetate) Oral Suspension, Methadone Hydrochloride Oral Solution, Methylphenidate Hydrochloride Oral Solution, Metoprolol Succinate Extended-Release Tablets, Mycophenolate Mofetil Tablets, Nabumetone Tablets, Naratriptan (naratriptan hydrochloride) Tablets, Norethindrone Tablets, Oxymorphone Hydrochloride Extended-Release Tablets, Phentermine Hydrochloride Capsules, Podofilox Topical Solution, Pramipexole Dihydrochloride Tablets, Ranitidine Hydrochloride Syrup and Oral Solution, Rocuronium Bromide Injection, Sertraline Hydrochloride Tablets, Spironolactone Tablets, Sumatriptan Succinate Subcutaneous Injection, Tacrolimus Capsules, Theophylline Extended-Release Tablets, Triamcinolone Acetonide Dental Paste, Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) Tablets, Veltin (clindamycin phosphate and tretinoin) Gel, Zuplenz (ondansetron) Oral Soluble Film. Source: FDA
Generic Enoxaparin Sodium Injection Approved by FDA. 7/23/2010. The FDA approved the first generic version of the anti-coagulant Lovenox (enoxaparin sodium injection) to prevent deep vein thrombosis. Made from Heparin, the active ingredient is a naturally-derived complex mixture of sugar molecules. Source: FDA
REMS Released by FDA for Qualaquin (quinine sulfate) Use. 7/08/2010. The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) to inform patients and health care providers of the serious risks related to the misuse of Qualaquin. Qualaquin is approved for use in the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum only, but is often used (against FDA recommendations) to prevent nighttime leg cramps, which has resulted in serious side effects and may cause life-threatening hematological reactions, including thrombocytopenia, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura resulting in permanent kidney damage. Source: FDA
FDA Warns Against Use of Stolen Advair Diskus Inhalers. 7/16/2010. Certain Advair Diskus (fluticasone propionate and salmeterol inhalation powder) Inhalers reported stolen from a distribution warehouse in August 2009 have been found in pharmacies. The FDA warns against the use of these products as their safety and effectiveness cannot be assured. Patients in possession of any of the stolen products should immediately cease use and contact GlaxoSmithKline's Customer Response Center; pharmacists finding the stolen product in their stores should remove them from their shelves and contact the FDA's Office of Criminal Investigation (OCI).
The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:
Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers).
Source: FDA
Coumadin 1 mg Tablet Blister Packs Recall. Bristol-Myers Squibb is issuing a recall of certain lots of their Coumadin 1 mg Tablet Blister Packs because it was determined that the tablets may not meet specifications for isopropanol, which is used to maintain the active ingredient, Coumadin. Therapeutic levels may be affected, resulting in an increased risk of bleeding or clots, and therefore, heart attack or stroke. The recall includes the following lot numbers: Physician Sample Blister Packs: 9A48931A, 9A48931B, 9A48931C; HUD Blister Pack: 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B. Source: FDA
Ongoing Safety Review: Cancer Risk Association with Angiotensin Receptor Blockers (ARBs) ARBs may be associated with a small increased risk of cancer according to a meta-analysis of several clinical trials that captured adverse events related to cancer during the evaluation of ARBS. The study found the rate of new occurrences of cancer to be 7.2% in patients receiving ARBs and 6% in those not receiving them (risk ratio = 1.08, 95% CI 1.01-1.15), with no significant difference in cancer-related deaths. The FDA, however, currently believes that the benefits of ARBs continue to outweigh their potential risks. Source: FDA
Updates on Drug shortages. 7/01/2010. Acyclovir Tablets and Capsules, Atracurium injection, Fabrazyme (agalsidase beta), Furosemide Injection 10mg/ml, Haloperidol Decanoate Injection, Heparin Sodium Large Volume Premixed Infusion Solutions, Intravenous Fat Emulsion, Leucovorin Calcium Lyophilized Powder for Injection, Levoleucovorin (Fusilev) 50 mg single use vials, Naloxone Injection. Source: FDA
Generic Drug Approvals by the FDA. 7/01/2010. Alprazolam Tablets, Anastrozole Tablets, Articaine Hydrochloride 4% and Epinephrine 1:100,000 Injection, Azelastine Hydrochloride Ophthalmic Solution, Aztreonam Injection, Cetirizine Hydrochloride Tablets, Clindamycin Phosphate Topical Solution, Desoximetasone Cream, Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol, Famotidine Oral Suspension, Ganciclovir Injection, Glipizide and Metformin Hydrochloride Tablets, Hydrocodone Bitartrate and Ibuprofen Tablets, Hydrocodone Bitartrate and Acetaminophen Tablets, Isopto Carpine (pilocarpine hydrochloride) Ophthalmic Solution, Jalyn (dutasteride and tamsulosin hydrochloride) Capsules, Jevtana (cabazitaxel) Injection, Levetiracetam Injection, Lithium Carbonate Tablets, Lorazepam Oral Concentrate and Tablets, Pharmaceutical Associates, Meropenem Injection, Mycophenolate Mofetil Tablets, Namenda XR (memantine hydrochloride) Extended Release Capsules, Nifedipine Extended-Release Tablets, Oxaliplatin I.V. Injection, Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets, Scanlux-300 and Scanlux-370 (iopamidol) Injection, Risperidone Oral Solution, Sumatriptan Succinate Subcutaneous Injection, Ulesfia (benzyl alcohol) Lotion. Source: FDA
New Indication for Tasigna (nilotinib) Approved. 6/17/2010. The FDA approved a new indication for Tasigna (nilotinib) expanding its use to treat adult patients in earlier stages of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML). In a clinical trial of Tasigna, which is believed to block a signal that leads to leukemic cell development, treatment produced a major molecular response in twice as many patients as did Gleevec (imatinib). The most common non-blood-related drug reactions are rash, itching (pruritus), headache, nausea, fatigue, and muscle pain (myalgia). Serious blood-related drug reactions included decrease in bone marrow activity (myelosuppression), low level of platelets in the blood (thrombocytopenia), decrease in infection-fighting white blood cells (neutropenia), and anemia. Source: FDA
Jevatana (cabazitaxel) Approved to Treat Prostate Cancer. 6/17/2010. Jevatana (cabazitaxel), a chemotherapy drug used in combination with prednisone, was approved as the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel. Side effects in include decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure. Source: FDA
Fradulent Tamiflu Containing Penicillin. 6/17/2010. The FDA warns against a product being sold on the internet as "generic Tamiflu" which does not contain oseltamivir, Tamiflu's active ingredient, but cloxacillin, which will produce an anaphylactic reaction in those allergic to penicillin. Symptoms of anaphylaxis include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse, and are potentially life-threatening. Although the website from which the FDA purchased the product, which was labeled as oseltamivir, for testing is no longer operational, the fraudulent version is still likely to be found for sale on others. Source: FDA
Withdrawl of Mylotarg (gemtuzumab ozogamicin). 6/21/2010. Mylotarg (gemtuzumab ozogamicin), approved in 2000 for treatment of acute myeloid leukemia (AML), is being withdrawn from the market due to results from a clinical trial started in 2004. The study was stopped early when there was not only a lack of clinical benefit, but a greater number of deaths in Mylotarg users as compared to chemotherapy alone. Mylotarg will no longer be available to new patients, but those already receving this treatment may complete their therapy following consultation with their health care professional. Source: FDA
First Generic Effexor Extended Release Capsules Approved to Treat Major Depressive Disorder. 6/29/2010. The FDA approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) in 37.5 milligram, 75 milligram and 150 milligram strengths, to treat major depressive disorder. There is an included warning that, as an antidepressant medication, it may increase suicidal thoughts or actions in some children, teenagers, and young adults during the first few months of treatment. Source: FDA
Termination of the Emergency Use Authorization for Permivir IV, Tamiflu (oseltamivir), and Relenza (zanamivir). 6/22/2010. Emergency Use Authorizations were issued for Permivir IV, Tamiflu (oseltamivir), and Relenza (zanamivir) during the 2009 H1N1 influenza public health emergency, both of which expire on June 23, 2010. The unapproved use of these drugs will no longer be in effect. Clinical trials will continue to determine their safety and efficacy, and patients beginning treatment with these drugs on or before June 23 will be allowed to complete the treatment course. Remaining stocks of Permivir IV should be destroyed. Source: FDA,FDA
June 2010
Updates on Drug Shortages. 6/14/2010. Acyclovir Tablets and Capsules, Epinephrine Emergency Syringes, Ethiodol (Ethiodized oil) ampules, Fosphenytoin Sodium Injection, Gemfibrozil Tablets, Heparin Sodium Large Volume Premixed Infusion Solutions, Mexiletine Capsules, Mitomycin for injection, Mustargen (mechlorethamine HCL) injection, MVI injectable (Adult and pediatric), Nimbex (cisatracurium) injection, Pancuronium Injection, Propofol Injection, Sulfamethoxazole/trimethoprim injection, Technetium Tc99m Generators, Thyrogen (thyrotropin alfa) injection, Vecuronium Injection. For more details please click here. Source: FDA
Generic Drug Approvals by the FDA. 6/14/2010. Adapalene Gel, Advil (ibuprofen and phenylephrine hydrochloride) tablets, Alprazolam Extended-Release Tablets, Amlodipine Besylate and Benazepril Hydrochloride Capsules, Bicalutamide Tablets, Carbidopa and Levodopa Orally Disintegrating Tablets, Cefoxitin (cefoxitin sodium) Injection, Ceftazidime Injection, Chlorzoxazone Tablets...For more informationabout recently approved drugs please click here. Source: FDA
Liposyn and Propofol Recall. 6/10/2010. Hospira has expanded its recall of Propofol and Liposyn to include lots distributed between December 2008 and April 2010. Several of the injectable products' containers may contain stainless steel particles that do not dissolve in blood and could act as emboli, impeding blood flow. The FDA is recommending that anyone with an existing inventory should quarantine the products immediately and arrange for their return. Source: FDA
New Injectable Osteoporosis Treatment Approved. 6/01/2010. The FDA approved the use of Denosumab (Prolia) to treat Osteoporosis in postmenopausal women. Prolia is an injectable treatment, administered subcutaneously once every 6 months, that increases bone mass and strength and reduces the incidence of vertebral, non-vertebral, and hip fractures. Common side effects include back and musculoskeletal pain, pain in the extremities, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, dermatologic reactions, and a contribution to the occurrence of osteonecrosis of the jaw, atypical fractures, and delayed fracture healing due to the significant suppression of bone turnover. Source: FDA
Potential Contamination of Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin. 6/01/2010. The presence of white matter in IV bags manufactured by Claris Lifesciences Limited is being investigated, and, in one case, has been identified as a Cladosporium mold, which can cause infections in susceptible patients. Claris is initiating a recall of all lots of the products manufactured on this same manufacturing line, which include metronidazole, ciprofloxacin, and ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. These products should be immediately removed from pharmacy inventories, and any patients who have received these products should be observed for illness. Note: Sagent's IV bags of ciprofloxacin are not made by Claris and are not subject to this recall. Source: FDA
May 2010
PediaCare Children's Products Recall. 5/29/2010. Blacksmith Brands initiated a recall of PediaCare Multi-Symptom Cold, PediaCare Long Acting Cough, PediCare Decongestant, and PediaCare Allergy and Cold as a precautionary step, because the McNeil plant at which they were manufactured has been found to have serious problems in meeting FDA's good manufacturing practice requirements. Source: FDA
New Treatment for Late-Onset Pompe Disease Approved. 5/25/2010. Pompe disease is a rare genetic disorder in which the body does not produce enough of the enzyme called acid alpha-glucosidase which functions to convert glycogen into energy. The absence of this interaction results in a build up of glycogen in the cells, weakening the heart and muscles. The FDA approved the use of Lumizyme (alglucosidase alfa) in late-onset (non-infantile) Pompe disease patients aged 8 years and older to replace the deficient enzyme in order to reduce the accumulated glycogen. Common side effects are infusion-related reactions including severe allergic reactions, hives, diarrhea, vomiting, shortness of breath, itchy skin, skin rash, neck pain, partial hearing loss, flushing, pain in extremities, and chest discomfort. Currently, the only other treatment available in the United States, Myozyme, has been in short supply and reserved to treat infants and children. Source: FDA
Generic Drug Approvals by the FDA. bethanechol chloride, buprenorphine HCl, bupropion HCl, carbinoxamine maleate, cefepime and dextrose, glimepiride tablets, irinotecan HCl injection, metronidazole, naratriptan tablets, protriptyline HCl, tamsulosin HCl, tramadol HCl extended release capsules, trandolapril and verapamil HCl extended release tablets. Source: FDA
New Four-Phasic Combination Oral Contraceptive Approved. 05/06/2010. The FDA approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle. Source: FDA
Naltrexone (Vivitrol) for Injection Associated with Injection Site Reactions: New Medication Guide Required for Patients. 05/04/2010. Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009. Some people on Vivitrol treatment have had severe reactions at the site of the injection (injection site reactions), including tissue death (necrosis). Some of these injection site reactions have required surgery. Source: FDA
Eltrombopag (Promacta): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease. 05/12/2010. GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with eltrombopag, a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura. The ELEVATE study, a randomized, double-blind, placebo-controlled, multinational study was terminated following the identification of an imbalance of thrombosis of the portal venous system in the patients treated with eltrombopag versus matching placebo. Six patients (4%) in the eltrombopag group and one (1%) in the placebo group experienced a thrombotic event of the portal venous system. Five of the six patients treated with eltrombopag experienced the portal venous thrombosis at platelet counts above 200,000/μL. GSK has communicated this safety finding to clinical trial investigators and regulatory agencies. GSK is working with regulatory agencies to include this safety information in the label. Source: MedWatch
FDA's Ongoing Evaluation of GnRH Agonists and Risk of DM and CVD. 05/03/2010. The FDA is continuing their evaluation of whether Gonadotropin-Releasing Hormone (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. GnRH agonists (sold under the brand names Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel) are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. The FDA's review is ongoing and they have not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer. Source: FDA
Injectable Ibuprofen (Caldolor) Approved for Pain, Fever and as an Adjunct to Opioids. 05/2010. The approval of injectable ibuprofen provides another parenteral NSAID option in addition to injectable ketorolac (Toradol). One big difference is no specific limitation to duration of use like seen with injectable ketorolac (i.e., 5 day limitation).
Mechanism of Action: Nonselective competitive inhibition of the COX enzyme.
Dosage Form & Dosing: Pain: 400-800 mg IV x 30 minutes every 6 hours as needed. Fever: 400 mg IV x 30 minutes, followed by 400 mg every 4-6 hours or 100-200 mg every 4 hours as needed. The patient should be well hydrated before IV infusion and Caldolor should also be diluted. Comes in vials: 400 mg/4 mL and 800 mg/8 mL.
Half-life: 2 hours
Drug Interactions: ACE inhibitors, ARBs, diuretics, aspirin due to risks of renal failure. Lithium and methotrexate.
Side Effects (≥5%): Nausea, vomiting, flatulence, hemorrhage and dizziness.
Pregnancy Category: Avoid after 30 weeks of gestation
Source(s): Cumberland Pharmaceuticals
April 2010
Updates on Drug Shortages. 04/12/2010. Acyclovir (tablets and capsules), Elspar, Levorphanol, Mechlorethamine (Mustargen) injection, Propofol Injection. Source: FDA
New Heparin Sodium Less Active. 04/07/2010. The FDA provided results from laboratory studies performed which show that Heparin Sodium, USP (heparin) made under the new United States Pharmacopeia (USP) Monograph ("new heparin") has approximately 10% less blood-thinning (anticoagulant) activity compared to heparin prepared using the previous ("old") USP Monograph. The studies were performed in order to better understand the clinical impact of the change in potency for heparin. Source: FDA
Losartan Goes Generic. 04/07/2010. The FDA approved the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively. Source: FDA
New Formulation of OxyContin Hopes to Prevent Abuse: 04/05/2010. The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication. The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended. Source: FDA
March 2010
Simvastatin and Risk for Muscle Injury at High Doses. 03/19/2010. FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, simvastatin (Zocor) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. Comment: This is nothing new (despite this release) as it has been thoroughly evaluated and known for some time due to the National Lipid Association's Statin Safety task Force Muscle Safety Expert Panel. Source: FDA PubMed
Drug Shortage Updates from the FDA. 03/22/2010. The following drugs have updates on the status and rationale for the shortages: Acyclovir, Cleviprex, Ethiodol, Mustargen, Oxsoralen. Source: FDA
New Drug Approval for a Rare Genetic Disorder: Velaglucerase alfa (VPRIV) for Gaucher disease. 03/22/2010. The FDA recently approved the use of velaglucerase alfa for the treatment of Gaucher disease, which is a rare genetic disorder in which children have a mutation in the GBA gene and therefore do not make enough of the lysosomal enzyme, beta-glucocerebrosidase. This enzyme deficiency results in an inability to convert sphingolipid glucocerebroside into glucose and ceramide, thereby resulting in the formation of foam cells or "Gaucher cells" that accumulate in the liver, spleen, bone marrow and other organs. This accumulation can then cause anemia an thrombocytopenia. Velaglucerase alfa is given as a 60 units/kg dose that is administered by a 60 min IV infusion every other week. The only other treatment option available is imiglucerase (Cerezyme), which is currently in short supply. Source: FDA Shire
New Prenatal Vitamin to Reduce Morning Sickness Available. 03/01/2010. This new prescription prenatal product is marketed as CitraNatal B-Calm and contains higher levels of vitamin B6 (25 mg, followed by two more 25 mg tablets for a total of 75 mg over 24 hours), 125 mg of calcium citrate, 20 mg of carbonyl iron, 1 mg of folic acid, 120 mg of vitamin C, 400 IU of cholecalciferol (vitamin D3). Source: Mission Pharmacal
Name Change for Kapidex Approved by the FDA. 03/04/2010. In an effort to avoid confusion with the brand name products, Casodex and Kadian, the FDA approved a name change for dexlansoprazole from Kapidex to Dexilant. Dexlansoprazole is a proton pump inhibitor (PPI). Source: FDA
First-Time Generics from February 2010. O3/04/2010. Desloratadine 5 mg tablets marketed as Clarinex is now generic. In addition, imiquimod 5% cream marketed as Aldara Cream is now also generic. Source: FDA
Generic Tamsulosin Receives Approval for BPH. 03/02/2010. The U.S. Food and Drug Administration has approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination. Source: FDA
Byetta Gets Warning About Causing Altered Kidney Function. 03/01/2010. The FDA reported that from April 2005 to October 2008, it received 78 reports of altered kidney function in patients treated with Byetta. It is important to note that some of the patients had pre-existing kidney disease and other risk factors for developing kidney problems. Acute renal failure occurred in 62 patients and renal insufficiency in 16 patients. The FDA also recommended the following: monitor patients for signs and symptoms of altered kidney function, including increased serum creatinine, changes in urination, unexplained swelling, increases in blood pressure, lethargy, or dull ache in the mid to lower back. Consider discontinuing the drug if a patient's kidney function worsens while using it. Source: FDA
Warning About Counterfeit Alli. 03/01/2010. The FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for over-the-counter use, contains a substance that prevents the absorption of fats from the diet. The FDA reports that counterfeit Alli products can be identified by the following: 1) missing lot number on the outer cardboard packaging; 2) an expiration date that includes a month, day and year-the real Alli has only a month and year; 3) The foil safety seal on the mouth of the counterfeit bottle has no writing-the seal on the real Alli says "Sealed for your protection"; 4) capsules contain a white powder-the real capsules contain small white pellets; 5) packaged in a plastic bottle that has a slightly taller and wider cap than the real Alli, with coarser ribbing. Source: FDA
February 2010
Procrit, Epogen and Aranesp - Required Use Only Under a REMS Risk Management Program. 02/16/2010. FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a Risk Evaluation and Mitigation Strategies (REMS) management program. As part of the risk management program, a medication guide explaining the risks and benefits of erythropoiesis stimulating agents (ESAs) must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, the drug manufacturer, Amgen, will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. Source: FDA
Lamotrigine (Lamictal XR) New Drug Approval. 02/16/2010. The FDA reported the approval of a new drug application for the use of lamotrigine (Lamictal XR) as adjunctive therapy for Primary Generalized Tonic-Clonic (PGTC) seizures in patients ≥ 13 years of age. The manufacturer is GlaxoSmithKline. Source: FDA
Olmesartan (Benicar) Receives New FDA Approved Indication. 02/16/2010. The FDA approved new labeling for the use of olmesartan for the treatment of hypertension in pediatric patients 6 to 16 years of age. Source: FDA
Cialis Product Labeling Change. 02/16/2010. The FDA reported the following information: "This "Changes Being Effected" supplemental new drug application provides for updates under Recent Major Changes in the HIGHLIGHTS OF PRESCRIBING INFORMATION and revisions to CONTRAINDICATIONS (4.2) and WARNINGS AND PRECAUTIONS (5.11) sections of the Physician Insert, and to the Patient Package Insert, to achieve consistency with the ADCIRCA labeling and to replace a previous contraindication. The updated labeling provides for a revised warning against use of CIALIS with other phosphodiesterase (PDE5) inhibitors including ADCIRCA. ADCIRCA also contains tadalafil and is indicated for the treatment of pulmonary arterial hypertension. In addition, the updated labeling replaces a previous contraindication in patients with known serious hypersensitivity to tadalafil. Hypersensitivity reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, have been reported." Source: FDA
Drug Shortages Updates as of 02/22/2010. Updates, rationale for delays, availability information now available for: acyclovir, heparin sodium premixed infusions, mexiletine, propofol, thyroid (desiccated) tablets. Source: FDA
FDA Alert: Changes to Ritonavir (Norvir) Dosing - Tablets Are Not The Same as Capsule. 02/10/2010. Unlike the capsule formulation, Norvir tablets must be taken with meals and are not bioequivalent to Norvir capsules. The changes furthermore highlight that NORVIR tablets should be swallowed whole, and not chewed, broken or crushed. Source: FDA
Rosuvastatin (Crestor) Gets a New FDA Approved Indication: 02/09/2010. Based on the JUPITER Trial, the FDA granted approval to rosuvastatin for the primary prevention of cardiovascular disease to reduce the risk of stroke, heart attack, and the risk of arterial revascularization procedures (including coronary artery bypass graft, or bypass grafting of a peripheral artery or carotid artery, or angioplasty or stent placement) in individuals who have no clinically evident heart disease but are at an increased risk of heart disease due to the combined effect of the following risk factors: Age (> 50 years in men; > 60 years in women), an elevated high-sensitivity C-reactive protein level (> 2 mg/L), and presence of at least one additional cardiovascular risk factor (e.g., high blood pressure, low HDL-C, smoking, or a family history of premature heart disease). Source: FDA
Drug Shortage Updates as of 02/07/2010. Updates, rationale for delays, availability information now available for: acyclovir, indomethacin injection, methotrexate injection, mitomycin injection, neupro, pentothal, vecuronium injection. Source: FDA
Natalizumab (Tysarbi) and Risk for PML. 02/05/2010. The FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Source: FDA
Caspofungin (Cancidas) Labeling Changes Regarding Hepatic Effects. 02/05/2010. Language now specifies both adults and pediatric patients. For example the Warnings and Precautions section now reads, "In some adult and pediatric patients with serious underlying conditions who were receiving multiple concomitant medications with CANCIDAS, isolated cases of clinically significant hepatic dysfunction, hepatitis, and hepatic failure have been reported; a causal relationship to CANCIDAS has not been established. Patients who develop abnormal liver function tests during CANCIDAS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing CANCIDAS therapy." Source: FDA
Darunavir (Prezista) for HIV Infection Label Change. 02/04/2010. The Package Insert and Patient Package Insert for darunavir was updated with 96 week data from two trials, one in treatment-experienced patients and one in treatment-naive patients to support the use of darunavir tablets for the treatment of HIV-1 infection. Source: FDA
Trazodone (Oleptro Extended- Release) Approved for Major Depressive Disorder. 02/02/2010. Oleptro was approved for major depressive disorder in adults only. Mechanism & Dosing: Selective inhibition of neuronal uptake of serotonin and is an antagonist at 5-HT-2A/2C serotonin receptors.
Dosage Form & Dosing: 150 mg and 300 mg bisectable tablets. Initiate at 150 mg daily. Can increase by 75 mg per day every 3 days until max dose of 375 mg per day. Tablet can be broken is half but NOT crushed.
Half-life: 10 hours
Drug Interactions: Substrate of CYP3A4. Avoid with monoamine oxidase inhibitors (MAO).
Contraindications & Precautions: Increased suicidal risk, risk for serotonin syndrome, QT-prolongation and patients with heart disease.
Side Effects (≥5%): Somnolence/sedation, dizziness, constipation, blurred vision.
Pregnancy Category: C
Source(s): FDA Labopharm
Collagenase Clostridium Histolyticum (Xiaflex) Approved for Dupuytren's Contracture. 02/02/2010. The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers. Dupuytren's contracture affects the connective tissue found beneath the skin in the palm of the hand. Too much collagen can build up, forming thick, rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally. The disorder is most common in Caucasians and in men over age 50. Xiaflex is a biologic drug made from the protein product of a living organism.
Mechanism & Dosing: It works by breaking down the excessive buildup of collagen in the hand.
Dosage Form & Dosing: Single dose glass vials containing 0.9 mg of lyophilized powder. Injection administered by experience provider.
Half-life: N/A
Drug Interactions: N/A.
Contraindications & Precautions: Tendon rupture, caution in patients who are on or received anticoagulants in the last 7 days.
Side Effects (≥25%): Edema, contusion, injection site reaction, bleeding and pain at site of injection.
Pregnancy Category: B
Source(s): FDA Auxilium
January 2010
Olanzapine (Zyprexa) Labeling Changes Related to Adolescents. 01/29/2010. Eli Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that:
Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.
Section 17.14, Need for comprehensive Treatment Program in Pediatric Patients: Zyprexa is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age.
Source: FDA
Didanosine (Videx) Label Change to Include New Serious Liver Disorder. 01/29/2010. The FDA sent out an alert regarding changes to the product labeling for didanosine and its association with the development of a rare, but serious condition called non-cirrhotic portal hypertension. This alert came after the FDA reviewed 42 post-marketing cases representing mostly males and ages ranging from 10 to 66 years. The time frame for the identification of this disorder in relation to the initiation of didanosine ranged from months to years. Source: FDA
Liraglutide (Victoza) FDA Approved for type 2 Diabetes. 01/25/2010. The FDA today approved liraglutide (Victoza), a once-daily injection to treat type 2 diabetes in some adults.
Mechanism: It is an acylated human Glucagon-Like Peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1. Upon activation of GLP-1, it increases cAMP leading to an increase in insulin release in the presence of elevated glucose concentrations. Upon decreases in serum glucose insulin secretion subsides. Glucagon secretion is also inhibited in a glucose-dependent manner.
Dosage Form & Dosing: 0.6 mg SC once daily independent of meals. After 1-week, increase dose to 1.2 mg SC once daily.
Half-life: 13 hours
Drug Interactions: None known at this time but does delay gastric empyting.
Contraindications & Precautions: Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.
Side Effects: Headache, nausea, diarrhea and anti-liraglutide antibody formation. Also some concerns over pancreatitis.
Pregnancy Category: C
Source(s): FDA Novo Nordisk
Ampyra FDA Approved to Improve Walking in Patients with MS. 01/23/2010. The FDA approved the first drug, dalfampridine (Ampyra), for the improvement of walking speed in patients with multiple sclerosis (MS).
Mechanism & Dosing: It is a potassium channel blocker that is known to increase the conduction of action potentials in demyelinated axons.
Dosage Form & Dosing: 10 mg tablets. Administered up to 10 mg twice daily without regard to food.
Half-life: 5.2 - 6.5 hours
Drug Interactions: None known at this time. It is not a substrate, inhibitor or inducer of any of the cytochrome P450 enzymes or efflux transporter, P-glycoprotein (PgP; MDR1).
Contraindications & Precautions: It is contraindicated in patients with a creatinine clearance (CrCl) ≤ 50 ml/min and should be used in caution in patients with a CrCl between 51-80 ml/min also at risk for seizures.
Side Effects (≥2%): UTI, insomnia, dizziness, headache, nausea, back pain, balance disorder, relapse of MS, constipation, dyspepsia, pharyngolaryngeal pain.
Pregnancy Category: C
Source(s): FDA Acorda Therapeutics
Sibutramine (Meridia) - New Contraindications from the FDA. 01/21/2010. Based on the FDA's internal review of additional data indicating an increased risk of heart attack and strokes in patients with a history of cardiovascular disease while on sibutramine, the FDA notified healthcare professionals today about the new contraindications to its use: 1) history of coronary artery disease; 2) history of stroke or transient ischemic attack (TIA); 3) history of heart arrhythmias; 4) history of congestive heart failure; 5) history of peripheral artery disease; uncontrolled hypertension (e.g., > 145/90). Source: FDA
Omega-3 Fatty Acid Levels Decrease the Rate of Telomere Shortening. 01/20/2010. A prospective cohort study of 608 patients with stable coronary artery disease (CAD) and who were followed for a median of 6 years found that the rate of telomere shortening was fastest in patients with the lowest levels of omega-3 fatty acids (DHA and EPA), whereas patients with the highest levels had the slowest rates or telomere shortening. Comment: The telomere is an area at the end of a chromosome that compensate for incomplete DNA replication. Their presence helps to prevent chromosomal deterioration that is associated with aging. Their rate of shortening directly affects that cells ability to replicate appropriately. Source: JAMA
Sirolimus (Rapamune): Alert - Change to Drug Monitoring Recommendations. 01/11/2010. Wyeth and the FDA are alerting healthcare providers about new findings related to the appropriate interpretation of sirolimus drug concentrations. They warn that the measured concentrations are assay and laboratory-dependent. As such, this should be taken into consideration when making dosage adjustments especially if the patient is getting their labs at another facility where changes in assays may not be communicated in a report to an outside physician. Failure to consider this could result in allograft rejection if drug concentrations are too low or toxicity if concentrations are too high. Source: FDA
December 2009
Nzu or Salted Nzu (Calabash clay, Calabar stone, Mabele, Argile and La Craie) - Traditional Remedy for Morning Sickness. 12/31/2009: The Texas Department of Health and the FDA released a warining to healthcare professionals and consumers that this natural remedy sold in African specialty store may contain high levels of lead and aresenic. Lead can increase the risk for effects on the brain and nervous system, especially in a developing child. Arsenic is carcinogenic of which long-term exposure has been associated with cancers of the bladder, lung and skin. It is recommended that all use of this product be avoided and for patients to contact their physician. Sources: Texas Department of Health FDA
New Generic Drug Approvals include: 12/24/2009: ampicillin/sulbactam (to ACS Dobfar), carvedilol (to Wockhardt Limited), ciprofloxacin injection (to Hikma Farmaceutica), epirubicin hcl injection (to EBEWE Pharma), etomidate injection (to PharmacForce, Inc.), mycophenolate mofetil capsules (to Endo Pharmaceuticals, Inc.), risperidone orally disintigrating tables (to Sandoz Inc.). Source: FDA
Ezetimibe (Zetia) & ezetimibe/simvastatin (Vytorin). 12/22/2009: As a follow up to an early communication in August 2008, the FDA released another early communication today to reflect their internal analysis on the association between ezetimibe and an increase risk of cancer and cancer-related death when compared to placebo based on preliminary data from the SEAS trial. The FDA reviewed additional data from the SHARP and IMPROVE-IT trials and found that this association to be unlikely and is not recommending healthcare professionals or consumers to stop using ezetimibe based on this potential concern. Source: FDA
Cromolyn sodium oral solution: 100 mg/5 mL unit-dose ampule. 12/22/2009: New generic drug approval for Genera Pharmaceuticals, LLC. Comment: This is just another generic cromolyn sodium option for inhalation for the prevention of bronchospasm and is bioequivalent to Gastrocom by Azur Pharma, Inc. Source: FDA
Tiotropium bromide (Spiriva HandiHaler). 12/18/2009: Change in product insert to include new information in support of clinical efficacy. Even though the primary endpoint of a 4-year randomized, double,-blind, placebo-controlled, multicenter clinical trial in 5992 COPD patients did not show a difference in the rate of disease progression (i.e., rate of decline in FEV1), a secondary endpoint on the risk of exacerbation was reduced by 14% with tiotropium (HR = 0.86; 95% CI, 0.81-0.91; p<0.001) and a median time to first exacerbation was delayed from 12.5 months (95% CI, 11.5-13.8) in the placebo group to 16.7 months (95% CI, 14.9-17.9) in the tiotropium group. As such, the approved indications now include wording that tioptropium is indicated for reducing COPD exacerbations. Comment: It is important to recognize that this was compared to placebo controlled trial and that patients were also permitted to use other respiratory medications other than anticholinergics. Tiotropium's advantages include its long duration of action and once daily administration. Sources: FDA Boehringer Ingelheim
Diclofenac sodium topical gel (Voltaren Gel 1%). 12/04/2009: Changes to the product labeling has occurred to reflect postmarketing reports for the potential elevation of liver function tests. Most of the cases appear to occur during the first month but can occur at any time per the FDA. New recommendation: liver enzymes (transaminases) should be monitored within 4-8 weeks after initiating treatment. Sources: FDA Product Labeling
Valproic acid (Depakene; Stavzor) and divalproex sodium (Depakote). 12/03/2009: The FDA sent out another reminder to healthcare professionals about the increased risk for neural tube, craniofacial and cardiovascular malformations in babies exposed during pregnancy. The rates of neural tube defects are highest during the 1st trimester with rates 30-80-fold greater than the general population. When compared to women taking other antiepileptic drugs, the risk of neural tube defects is almost 4-fold higher in women taking valproate derivatives. The benefits of valproate use should clearly be outweighed to the risk associated with its use. As in the general population, pregnant women should take a folic acid supplement even though this may not eliminate the risk. Source: FDA
Fosamprenavir (Lexiva) - a protease inhibitor (PI) used in treating HIV. 12/03/2009: A dear healthcare professional letter was sent out from the GlaxoSmithKline to alert them of the changes in product labeling regarding an association between Lexiva and myocardial infarction (MI) and dyslipidemia in HIV infected adults. This warning comes from a case-controled study nested in the French Hospital on HIV which reported the association to be an Odds ration (OR): 1.52 per additional year of exposure; 95% CI, 1.19-1.95. Comment: As a reminder, the risk for MI has already been associated with the PI class of medications per the D:A:D Study. While, this is not of a major surprise, it is consistent with other data and thus warrants attention. Source: FDA
| 1234 | 1. |
Are there any differences among the proton pump inhibitors (PPIs) in their ability to inhibit the activation of clopidogrel (Plavix) through the cytochrome P450 (CYP) enzyme system?Link to Answer |
| 2. |
Are the any updates to the drug interaction between clopidogrel (Plavix) and proton pump inhibitors in patients who have received percutaneous coronary intervention (PCI) involving stent placement? Link to Answer | |
| 3. |
What data are available regarding the efficacy of clopidogrel (Plavix®) on platelet inhibition or reactivity when given with a proton pump inhibitor (PPI)? Link to Answer | |
| 4. |
Are there any known drug interactions between histamine-2 receptor antagonists (H2RA) and clopidogrel (Plavix) that could compromise the efficacy on platelet inhibition? Link to Answer | |
| 5. |
Are there any studies evaluating the use of histamine-2 receptor antagonists (H2RA) with clopidogrel (Plavix) as it relates to clopidogrel's ability to prevent stent thrombosis or platelet aggregation? Link to Answer |
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