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FDA Warns of Risky Weight Loss Pills
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FDA Tells Consumers Not to Use More Than 25 Weight Loss Products Due to Undeclared, Illegal Ingredients
Reviewed By Louise Chang, MD
Dec. 22, 2008 -- The FDA today warned consumers not to buy or use more than 25 products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may be risky.
Those products, which may be sold online or in stores as "dietary supplements," are:
"These products have not been approved by the FDA, are illegal, and may be potentially harmful to unsuspecting consumers," states an FDA news release.
Some of the weight loss products that the FDA is warning about claim to be "natural" or to contain only "herbal" ingredients.
But FDA tests found that the some of the products contained undeclared ingredients including sibutramine (a controlled substance), rimonabant (a drug not approved in the U.S), phenytoin (an antiseizure drug), and phenolphthalein (a solution used in chemical experiments and a suspected cancer-causing agent).
In some cases, the amount of active pharmaceutical ingredients in the products far exceeded the FDA-recommended levels, posing a health risk.
The FDA notes that sibutramine can cause high blood pressure, seizures, fast heart rate, palpitations, heart attack, or stroke. It can also interact with other drugs, and its safety hasn't been established in pregnant and lactating women, or in children younger than 16.
The FDA also points out that rimonabant, a drug which the FDA considered but didn't approve, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe, where it is an approved drug, over the last two years.
If you're using any of the weight loss products that the FDA is warning about, the FDA advises you to stop taking those products and consult your health care professional immediately -- and to seek guidance from a health care professional before purchasing weight loss products.
You can also report any serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting system. File a report on the FDA's web site or call 800-FDA-1088.
The FDA says it has asked for product recalls and may take further enforcement actions against the companies marketing the tainted weight loss products.
SOURCES: News release, FDA.
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