FDA Finds Dangerous Drug in Counterfeit ED Product

But, like other once-promising weight-control drugs such as phentermine and orlistat, sibutramine had its downside, and it was a big one: reports of sudden death, heart failure, renal failure, and gastrointestinal problems led the FDA to question its safety. The Sibutramine Cardiovascular Outcomes Trial (SCOUT) was initiated as part of a postmarket requirement to look at the cardiovascular safety of sibutramine after its European approval. Results, published in the European Heart Journal in 2007, were daunting: The trial demonstrated a 16 percent increase in the risk of serious cardiac events, including nonfatal heart attack, nonfatal stroke, the need to be resuscitated once the heart stopped, and death in a group of patients given sibutramine compared with a group given placebo. Even more disappointing was the small difference in weight loss between the placebo group and the group that received sibutramine.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Under pressure from the FDA, Abbott Laboratories agreed to voluntarily withdraw Meridia from the U.S. market on October 8, 2010.

The Extenze incident isn't the first time sibutramine has appeared, undeclared, in over-the-counter products. In December 2008, the FDA issued an alert to consumers naming 27 products marketed as dietary supplements for weight loss that illegally contained undisclosed amounts of sibutramine. An additional 34 sibutramine-contaminated products were recalled by the FDA on April 22, 2009.

In January 2010, the FDA warned the public about a counterfeit version of the weight-loss drug Alli being sold over the Internet, particularly at online auction sites. Authentic versions of Alli contain over-the-counter amounts of orlistat; the counterfeit versions contained high doses of sibutramine.

Despite the FDA's efforts, counterfeit and contaminated products containing sibutramine and other undeclared ingredients offered for weight loss and treatment of erectile dysfunction continue to be detected.

"These contaminants pose a risk precisely to the individuals for whom the product is advertised," said Gary Kennedy, M.D., a professor of psychiatry and behavioral science at Montefiore Medical Center, Albert Einstein College of Medicine. "Physicians should routinely ask patients about their use of supplements, especially in the context of a new prescription or when questions about side effects arise. When a patient uses an FDA-approved medication for erectile dysfunction, the risks are quantified and largely predictable. With nutraceuticals and supplements, the situation is ‘buyer beware’ because, as these recalls demonstrate, we don't know what is in those formulations."