Herbal & Natural Medicine News 

JULY 2010

Potentially Harmful Ingredients Found in Que She Weight Loss Capsules. 7/20/2010. FDA analysis of Que She, marketed as an herbal weight loss supplement, found several active ingredients not listed on the product label, including propranolol, sibutramine, and ephedrine, which pose risks to patients with cardiovascular conditions, and fenfluramine which was withdrawn from the U.S. market in 1997 as it was found to cause heart valve damage. The active ingredients may also interact with other medications. People who have purchased Que She should stop taking the product immediately and contact a health care provider. Source: FDA

Vialipro Recall. 7/20/2010. Good Health, Inc. is conducting a voluntary recall of the dietary supplement Vialipro, which was found to contain Sulfoaildenafil in certain batches. Sulfoaildenafil’s presence makes the drug unapproved and may react with some prescription drugs causing a dangerous drop in blood pressure. Consumers should discontinue use and return Vialipro to Good Health, Inc. The recalled lot numbers can be found in Good Health, Inc.’s press release. Source: FDA

Slim-30 Herb Supplement Contains Undeclared Drug. 7/19/2010. Slim-30 Herb Supplement was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. The FDA has not approved this product which may cause substantial increases in blood pressure and pulse rate in certain patients and poses a risk for patients with previous cardiovascular conditions. Source: FDA

June 2010

Warning Against Arrow Brand Medicated Oil & Embrocation. 5/27/2010. The FDA declared the Arrow Brand Medicated Oil & Embrocation product, which claims to treat gas, coughs, colds, headache, colic, aches, pain, and influenza, to be unsafe due to the presence of methyl salicylate and camphor, which are toxic when ingested or applied to large areas of the body. The FDA is also testing the product for the presence of diethylene glycol (DEG), an ingredient used in antifreeze, which is also poisonous when ingested. Children are especially susceptible to poisoning, which in some cases have led to death, and ca be indicated by symptoms of abdominal pain, nausea, vomiting, diarrhea, headache, visual changes, dizziness and mental confusion. This product is not legally marketed and is sold primarily in specialty stores that serve Asian and Latino communities and on the Internet. Source: FDA 

Magic Power Coffee Reacts with Nitrates. 6/21/2010. The FDA warns consumers not to use Magic Power Coffee, because the product, marketed as a dietary supplement for sexual enhancement, contains hydroxythiohomosildenafil, which reacts with nitrates to cause dangerously low blood pressure. Consumers who have this product should stop use and report any related negative side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Source: FDA

Vitamin D Overdose Risk in Infants. 6/15/2010. The FDA warns against overdosing infants with liquid vitamin D, as some products on the market come with droppers that allow caregivers to give infants harmful amounts inadvertently. Infants should not receive more than 400 IUs of vitamin D a day as excessive amounts can cause nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue, and kidney damage. Source: FDA

May 2010

Vita Breath Dietary Supplement Contains 10,000x the Maximum Lead Requirement. 05/03/2010. The FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA's maximum recommended level for lead in candy. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. The FDA is working with state officials in New York and California to further investigate Vita Breath. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. No comments were posted as of 05/12/2010 from the American Herbal Products Association (AHPA).  Source: FDA

April 2010

The DIAMOND Study: DHA Supplementation and Infant Visual Acuity: 04/01/2010. Main Objective: Determine the effect of 4 amounts of DHA supplementation on the visual acuity of formula-fed infants at 12 month of age. Methods: This was a Prospective, Randomized Double-masked, Multicenter trial conducted at 2 sites (Dallas and Kansas City) that involved 343 healthy, term, formula-fed infants between the ages of 1-9 days. The infants were randomly assigned to be fed 1 of the following 4 infant formulas containing equivalent nutrient amounts, except for long-chain polyunsaturated fatty acids: control (0% DHA), 0.32% DHA, 0.64% DHA, or 0.96% DHA; DHA-supplemented formulas also provided 0.64% arachidonic acid. Results: Infants fed control formula had significantly poorer visual evoked potential visual acuity at 12 mo of age than did infants who received any of the DHA-supplemented formulas (P < 0.001). There were also no significant differences in visual evoked potential visual acuity between the 3 amounts of DHA supplementation for either site at any age tested. Source: Am J Clin Nutr

March 2010

Warning About Natural Medicines for Sexual Enhancement.  03/01/2010.  The reported that it did an investigation of a number of these sexual enhancement supplements found on the internet and determined that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl).  Taking these products while also taking nitroglycerin products can result in life-threatening decrease in blood pressure.  Source:  FDA

February 2010

Acute Selenium Toxicity Associated with the use of a Dietary Supplement.  02/08/2010.  Methods:  This was a case finding (defined as the onset of symptoms of selenium toxicity in a person within 2 weeks after ingesting a dietary supplement manufactured by "Company A," purchased after January 1, 2008) study where an initial and 90-day follow-up questionnaires were give to affected persons and evaluation of laboratory data where available.  Results:  The source of the outbreak was identified as a liquid dietary supplement that contained 200 times the labeled concentration of selenium. Of 201 cases identified in 10 states, 1 person was hospitalized. The authors found that that the median estimated dose of selenium consumed was 41,749 µg/d (recommended dietary allowance is 55 µg/d).  In 8 of these patients, the mean initial serum selenium concentration was 751 µg/L (reference range,  125 µg/L) and the mean initial urine selenium concentration of 7 patients was 166 µg/24 h (reference range,  55 µg/24 h).  Reported symptoms included: diarrhea (78%), fatigue (75%), hair loss (72%), joint pain (70%), nail discoloration or brittleness (61%), and nausea (58%). Symptoms persisting 90 days or longer included: fingernail discoloration and loss (52%), fatigue (35%), and hair loss (29%).  Comment:  This evaluation, along with many others in the past, reflects the need for a concern about the use of "natural" supplements by our patients.  Given the cost of healthcare, this is especially relevant since the medical work up to rule problems with similar symptoms is likely to be costly.  Source:  Arch Intern Med


Herbal Products and Potential Interactions in Patients with Cardiovascular Diseases.   02/04/2010.  Physicians from the Mayo Clinic published a nice review in the Journal of the American College of Cardiology highlighting the common herbal products that could adversely impact patients with cardiovascular diseases.  The American Herbal Products Association (AHPA) responded to the article by highlighting their stand that consumers should tell their doctors what herbs they are taking and that doctors become sufficiently informed to provide useful advice to their patients.   Source: JACC   AHPA

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


Ginko biloba Does Not Slow Cognitive Decline in Older Patients.  12/29/2009:  The Ginko Evaluation of Memory (GEM) study, which was funded by the National Center for Complimentary and Alternative Medicine (NCCAM) of the NIH, was a randomized, multicentered, double-blind, placebo-controlled clinical trial of 3,069 adults aged 72-96 with a mean follow-up of 6.1 years comparing patients who took ginko 120 mg or placebo twice daily.  Compared to placebo, ginko did not lessen cognitive decline in general, or on memory attention, visual-spatial construction, language, or executive functions.  This data is consistent with previous data. The American Herbal Products Association (AHPA) offered additional comment regarding the potential limitations to the study.  Comment: The was an indpendently funded, very well-designed study of the highest standards in clinical research which also had a good sample size and appropriate patient-oriented endpoints that are of clinical relevance.  Until other information would suggest otherwise, the benefits of ginko in this population is doubtful and should clearly be weighed against potential side effects.  Sources:  NCCAM  AHPA

Warnings To Herbal Manufacturers Making Claims About Swine Flu Remedy, Cure.  12/09/2009:  According to the American Herbal Products Association (AHPA), the trade associations of the dietary supplement industry reaffirmed its support for rsponsible sale and use of health-promoting vitamins, minerals, herbs and other dietary supplements.  Comment: This notification comes after a wave of warning letters from the FDA and FTC went out to numerous herbal manufacturers for inappropriate marketing of their products for the prevention and/or cure of H1N1 flu.  Source:  AHPA


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