FDA Panel rejects weight-loss drug Rimonabant

As promised, we bring you the latest on this drug:

Federal health advisers unanimously rejected a weight-loss drug after hearing testimony that it increases the risk of suicidal behavior. The manufacturer, Sanofi-Aventis SA, failed to show the drug rimonabant is safe, the panel said. The unanimous finding by the expert panel's 14 voting members made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.

"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, of The Rockfeller University. In studies, patients given the once-daily tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received sham treatment, Dr. Amy Egan, a FDA medical officer told federal health advisers. "The numbers of events are small, but in aggregate they are worrisome," Egan said.

The FDA is to make a final decision on the drug by July 27. The company proposes selling the drug under the brand name Zimulti. Rimonabant already is sold in Europe as Acomplia. The litany of mental problems associated with the drug clearly gave the panelists pause. "I think this is a drug that needs further understanding with respect to what it does to people's psyche," said panelist Dr. Sid Gilman, a University of Michigan neurologist.

"We strongly believe that it is causal," Egan said. She noted 88 percent of those reporting psychiatric problems while on the drug had no prior history of depression. Furthermore, patients in the studies were carefully screened and monitored, suggesting the problems would be more common should the drug enter broad use, Egan added. The screenings proposed by the company won't keep the depressed and obese from Zimulti, warned Lynn McAfee, head of medical advocacy for the Council on Size & Weight Discrimination, a fat acceptance group. "If this gets out to be a real big deal in the public, you can figure out how to answer those questions to get the drug," McAfee said. "It's not going to stop anyone." The potential market for the drug is huge, as obesity rates have exploded in the past two decades. Today, nearly one in three American adults age 20 or older is obese, according to government data. Dr. Sidney Wolfe, of the advocacy group Public Citizen, said the obese are more likely to be depressed. Many of them likely would take Zimulti along with the antidepressants they already use — with unknown consequences, Wolfe told panelists. Rimonabant blocks the same pleasure centers in the body activated when pot smokers get the munchies. Blocking the receptors leads to patients eating less and losing weight.

Courtesy Reuters

Now - we wait and see what the FDA does. There will be a lot of pressure on them either way!