The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.
"These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," says Dr. Janet Woodcock, director of the FDAâ€™s Center for Drug Evaluation and Research.
"Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."
The FDA has identified additional weight loss products and new undeclared active pharmaceutical ingredients.
The current list names 72 products including a like-named knockoff of the popular Slim-Fast product. Click here to read the complete list.
Last December, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. In January, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products.
The products, some of which are marketed as dietary supplements, are promoted and sold on various websites and in some retail stores and beauty salons. Some of the products claim to be "natural" or to contain only "herbal" ingredients, but actually contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements.
These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:
--sibutramine: an appetite suppressant available by prescription only and a controlled substance
--fenproporex: a controlled substance not approved for marketing in the United States
--fluoxetine: an antidepressant available by prescription only
--bumetanide: a potent diuretic available by prescription only
--furosemide: a potent diuretic available by prescription only
--rimonabant: a drug not approved for marketing in the United States
--cetilistat: an experimental obesity drug not approved for marketing in the United States
--phenytoin: an anti-seizure medication available by prescription only
--phenolphthalein: a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States
The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages consumers to seek guidance from a health care professional before purchasing weight loss products.
The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke.
Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks.
Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.