Drug News: Approvals, Warnings & Etc
July 2010
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
Updates on Drug Shortages. 7/20/2010. 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, Pancuronium Injection, Technetium Tc99m Generators. Source: FDA
Generic Drug Approvals by the FDA. 7/20/2010. Adapalene Cream, Alsuma (sumatriptan) Injection, Bupropion Hydrochloride Extended-Release Tablets, Butrans (buprenorphine) Transdermal System, Clindamycin Palmitate Hydrochloride Oral Solution, Clonidine Transdermal System, Desloratadine Orally Disintegrating Tablets, Doxycycline Capsules, Ergocalciferol Capsules, Heparin Sodium Injection, Methadone Hydrochloride Oral Solution, Mycophenolate Mofetil Tablets, Nabumetone Tablets, Naratriptan (naratriptan hydrochloride) Tablets, Phentermine Hydrochloride Capsules, Pramipexole Dihydrochloride Tablets, Spironolactone Tablets, Ranitidine Hydrochloride Oral Solution, Tacrolimus Capsules, Theophylline Extended-Release Tablets, Triamcinolone Acetonide Dental Paste, Veltin (clindamycin phosphate and tretinoin) Gel, Zuplenz (ondansetron) Oral Soluble Film. 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?
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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 | |
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What data are available regarding the efficacy of clopidogrel (Plavix®) on platelet inhibition or reactivity when given with a proton pump inhibitor (PPI)?
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| 4. |
Are there any known drug interactions between histamine-2 receptor antagonists (H2RA) and clopidogrel (Plavix) that could compromise the efficacy on platelet inhibition?
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| 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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