Meridia: FDA Issues Warning About Sibutramine

Washington, DCFollowing the announcement earlier this year that Meridia was being withdrawn from the market due to increased risk of Meridia side effects, some consumers might have turned to dietary supplements to help with their weight loss. The risk of Meridia heart attack and Meridia stroke may have led to the US Food and Drug Administration (FDA) requesting the weight loss medication be pulled from the market, but that has not stopped dietary supplement manufacturers from using sibutramine, the active ingredient in Meridia, in their products.

Now, the FDA has issued a news release warning about dietary supplements using undeclared or deceptively labeled ingredients. Specifically, the FDA is concerned about dietary supplements that include the active ingredients in FDA-approved drugs—such as Meridia, which was formerly approved by the FDA—even though those active ingredients do not qualify as dietary ingredients.

According to the FDA (12/15/10), in recent years, the agency has issued alerts concerning approximately 300 tainted products that were marketed as dietary supplements. The agency further says it received numerous complaints about injury linked to those products.

"These tainted products can cause serious adverse effects, including strokes, organ failure, and death," said FDA Commissioner Margaret A. Hamburg, M.D. "The manufacturers selling these tainted products are operating outside the law."

The FDA news release notes that among the most common categories of illegal products are weight loss products that contain active ingredients such as sibutramine. According to the FDA, "Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs)."

A concern is that products containing sibutramine might have side effects similar to Meridia, but consumers who use the dietary supplements might not be aware of those side effects, which can be serious.

Companies that sell and market tainted dietary supplements could face injunctions and criminal prosecution if they are caught.

No lawsuits have been filed in the US concerning Meridia; however, lawsuits have been filed in Canada. Meridia was pulled from the market after a five-year study showed a 16 percent increased risk of non-fatal heart attack and non-fatal stroke in patients who used Meridia.