Panel Rejects Weight-loss Drug Due to Increased Suicidal Thoughts

According to a June 14 Associated Press report, a panel of federal advisers has voted unanimously to reject the weight-loss drug rimonabant after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression. This move makes it unlikely that the U.S. Food and Drug Administration, which generally follows the panel's recommendations, will approve it.

In studies, patients who took the drug reported twice as many psychiatric side-effects, including depression, anxiety and sleep problems. "The numbers of events are small, but in aggregate they are worrisome," said Amy Egan, an FDA medical officer.

There was disagreement, however, over whether the psychiatric effects were due to the drug. Egan said, "We strongly believe it is causal," noting that 88 percent of those who reported psychiatric problems had no prior history of depression. Sanofi-Aventis SA, the manufacturer of the drug disagreed. Officials from the company suggested that depression screening and follow-up visits throughout the first year of treatment would curtail any problems.

The panelists did agree, however, that rimonabant is effective in helping patients lose weight. In yearlong studies, patients taking the drug lost about 14 pounds. In comparison, those receiving a dummy pill lost only about 4 pounds.

The FDA is due to make its final decision on the drug by July 27.

The proposed brand name for the drug in the U.S. is Zimulti. It is already sold in Europe under the name Acomplia.