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Agency raises concerns about drug-tainted supplements.

The Food and Drug Administration has issued a letter to manufacturers of dietary supplements expressing concern about supplements that contain undeclared drugs or drug analogs as their active ingredients.

Tests conducted by the agency "have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements," including phosphodiesterase type 5 inhibitors, such as sildenafil; anticoagulants, such as warfarin; beta-blockers, such as propranolol; and anticonvulsants, such as phenytoin, the letter said. Among the illegally marketed products are those containing drugs that have been withdrawn from the market for safety reasons, including the weight-loss drugs sibutramine and fenfluramine. The tainted products most commonly fall into the categories of weight loss, body building, and sexual enhancement products.

Also, the FDA announced a new RSS feed to alert consumers when a tainted product is identified and established new ways for industry to report products suspected of being tainted, either by sending an e-mail to or filing an anonymous report.

Since 2007, the agency has issued consumer alerts about almost 300 tainted products containing an active drug ingredient. The FDA has received "numerous reports" of adverse events and injuries associated with these products, including stroke, kidney failure, and death, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during a press briefing announcing the measures. No information was available on the specific number of deaths or injuries reported.

Dr. Sharfstein said health care providers should continue to report adverse effects thought to be tied to an adulterated dietary supplement in their patients to the FDA's MedWatch program at 800-FDA-1088.

--Elizabeth Mechcatie
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Title Annotation:NEWS FROM THE FDA
Publication:Clinical Psychiatry News
Date:Mar 1, 2011
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