AJN, American Journal of Nursing:
Aschenbrenner, Diane S. MS, RN
Diane S. Aschenbrenner recently retired as course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: firstname.lastname@example.org.
* The Food and Drug Administration has issued warnings about active pharmaceuticals found in products labeled as dietary supplements and sold as aids for weight loss, body building, or sexual enhancement.
The Food and Drug Administration (FDA) monitors over-the-counter (OTC) products, sold in stores or over the Internet, that it believes are tainted with pharmaceuticals or other hidden, potentially dangerous substances and issues public notifications to warn consumers about them. But the FDA doesn't test or evaluate all products sold as dietary supplements and cannot guarantee their ingredients.
The FDA recently issued warnings about hidden pharmaceuticals in several products that are advertised for weight loss, body building, or sexual enhancement. In the past, the FDA has found steroids in body enhancement supplements and issued warnings about the risk of adverse effects. More recently, FDA laboratory analysis confirmed that weight-loss products called Strawberry Balance, Bethel 30, Meizi Evolution, Extreme Body Slim, Fruit and Plant Slimming, and Paiyouji Plus contain sibutramine. Sibutramine was sold as a prescription drug to help with weight loss until it was found to be associated with cardiovascular events and strokes. It was removed from the market in October 2010. Strawberry Balance and Bethel 30 also contain phenolphthalein, an ingredient in some OTC laxatives until 1999, when the FDA reclassified it as “not generally recognized as safe and effective” because it is considered carcinogenic.
The FDA also determined by laboratory analysis that many sexual enhancement products contain sildenafil or vardenafil (the active ingredients in Viagra and Levitra, respectively), which are used to treat male erectile dysfunction. Supplements found to contain these hidden active drugs include Silver Sword, Reload, and Royal Dragon Herbal Tonic Balls. These drugs cause vasodilation and can produce hypotension, especially if combined with a nitrate product (such as nitroglycerin, which is used to treat angina pectoris and other heart-related conditions).
Nurses should ask all patients about their use of OTC dietary supplements. Patient education should stress that products marketed as dietary supplements don't need FDA approval or FDA confirmation that they're safe or effective. Health care providers and patients are encouraged to report any adverse effects of dietary supplements to the FDA at www.fda.gov/MedWatch/report.
Readers wanting information on any of the tainted supplements can go to www.fda.gov/Drugs/ResourcesForYou/Consumers, where links to all of the public notifications can be found.
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