The FDA recently issued a second round of warnings about weight-loss products. This time the list has grown to 72 products - including Herbal Xenicol, Slimbionic, and Xsvelten - and is warning consumers about products containing fenproporex, fluoxetine, furosemide and cetilistat.
For the current list of products on the FDA’s list, click here
“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,” said Janet Woodcock, M.D., director of the FDA’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,” Woodcock said.
The products on the FDA’s list - some of which are marketed as dietary supplements - are promoted and sold on various Web sites, 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.
Antidepressants, anti-seizure medication, experimental drugs
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; and
- 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 has inspected several companies associated with the sale of these products and is working on product recalls.
And if the companies are uncooperative, the FDA “may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.”
The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. (And perhaps check with your doctor in future, before taking any weight loss product.)
Seizures and sudden death
“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,” the FDA states in its warning.
“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.”
If you experience a serious reaction to any of these products, the FDA asks that you or your doctor report this to the FDA’s MedWatch Adverse Event Reporting program, either online, by regular mail, FAX or phone.
If you mail your information, you can download the postage-paid FDA form 3500, available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm and mail it to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Or FAX it to 1-800- FDA-0178.
Or you can call in your report at 1-800- FDA-1088.
For more information provided by the FDA on weight-loss products, click here