Weight Loss Drug Potentially being Taken Off the Market, FDA Warns about Side-Effects of Dimethylamylamine

A drug commonly found in weight loss supplements is now potentially being taken off the market. Reports from the U.S. Food and Drug Administration indicate that the drug, most commonly used in supplements promising weight loss, muscle building and performance enhancement drugs, can elevate blood pressure and could lead to cardiovascular problems, including heard attack, shortness of breath and tightening of the chest.

The stimulant known as dimethylamylamine (DMAA) will no longer be distributed or available for sale to consumers in the marketplace, according to the FDA.

Sixty reports of illnesses and deaths associated with supplements containing the drug have been received so far. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.

The FDA has warned companies that any dietary products containing the DMAA ingredient are illegal. Such warnings offer the quickest way at FDA's disposal to half further distribution of dietary supplements containing the drug in the marketplace. In fact, all but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions.

Yet, at this time, studies from USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements and is currently finalizing a formal response to further finalize the findings, according to Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Program.