More OTC weight-loss products deemed illegal.
In a statement, the agency announced that four ingredients--the antidepressant fluoxetine; the diuretic furosemide; fenproporex, an amphetamine derivative and controlled substance that is not approved in the United States; and cetilistat, a drug currently being studied for obesity in the United States and elsewhere--have been detected in OTC weight-loss products sold in the United States.
The illegal products are marketed as Herbal Xenicol, Slim-bionic, and Xsvelten, and have been added to a list compiled by the FDA of OTC weight-loss products that have been found to contain undeclared active pharmaceutical ingredients, which now includes 72 products. Previously identified ingredients include sibutramine, the active ingredient in the FDA-approved obesity drug Meridia; the anti-epileptic drug phenytoin; and rimonabant, an obesity drug that was denied approval in the United States because of neurologic and psychiatric side effects.
Some of the products contain prescription drugs that exceed the maximum recommended dosages. The products are sold on Web sites and in some retail stores and beauty salons. Most of the products appear to be manufactured in China, according to the FDA, which is working on getting these products recalled.
More information, including the full list of products, is available at www.fda.gov/cder/consumerinfo/weight_loss_products.htm. Serious adverse events associated with these products can be reported to MedWatch at 800-332-1088 or at www.fda.gov/MedWatch/report.htm.
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|Title Annotation:||NEWS FROM THE FDA; over the counter|
|Publication:||Internal Medicine News|
|Article Type:||Brief article|
|Date:||Apr 15, 2009|
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