Another Diet Pill Warning Coming from FDAJan 8, 2009 | Parker Waichman LLP
Another warning on illegal diet supplements will soon be issued by the U.S. Food & Drug Administration (FDA). Last month, the agency issued a warning on 28 such drugs. According to USA Today, the agency is set to add 41 more products to that list.
According to the FDA, these weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.
According to USA Today, these pills may contain undeclared drugs that may put health at risk, including:
- Sibutramine, the active ingredient in the FDA-approved weight-loss drug Meridia. It's a controlled substance that can cause seizures, heart attack or stroke.
- Rimonabant, the active ingredient in Acomplia, a diet pill that failed to win FDA approval and has been withdrawn in Europe.
- Phenytoin, an anti-seizure medication, and phenolphthalein, a suspected carcinogen.
The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.
Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. In Europe, this drug has been linked to five deaths and 720 adverse reactions in Europe over the last two years.
Michael Levy, director of the division of new drugs and labeling compliance at the FDA, told USA Today that the FDA has an ongoing initiative that is investigating these dangerous dietary supplements. "We are buying these products, and we are testing them, and we are considering what our options are." Levy said. "There is definitely the possibility that there could be criminal charges."