Panel urges FDA to reject diet pill linked to suicidal thoughts

Lest we forget that it is not just psych drugs that do this. From this USA Today report

Federal health advisers unanimously rejected an experimental diet pill Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.

The manufacturer, Sanofi-Aventis, failed to prove that the prescription medication rimonabant is safe for consumption, the panel said.

The 14-0 decision by the expert panel makes it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its advisory panels' advice, but it isn't required to do so.

"There is a reasonable suspicion we'd better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Jules Hirsch, a senior physician at New York's Rockefeller University.

Research shows that rimonabant blocks parts of the endocannabinoid system, which stimulates appetite and promotes the storage of calories as fat. It changes patients' sense of fullness and drive to eat.

Drug trials showed that obese patients who took a 20-milligram pill of rimonabant daily while cutting calories lost an average of about 14 pounds in three to six months compared with 3½ pounds for those taking a placebo.

However, patients taking the pill reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received a placebo, Amy Egan, an FDA medical officer, told the advisers. "The numbers of events are small, but in aggregate they are worrisome," she said.

Egan said 88% of those reporting psychiatric problems while on the drug had no history of depression.

The company believes the psychiatric problems were tied to pre-existing conditions. Sanofi-Aventis' Richard Gural said the drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who is taking antidepressant medication.

The company said in a prepared statement that it will work closely with the agency to "address the committee's recommendations."

The FDA is to make a final decision on the drug by July 26.

Sidney Wolfe, director of Public Citizen Health Research Group, testified that "the evidence for increased suicidal tendencies and depression is of particular concern for a drug targeted toward the obese, a population that has been shown to have a significantly higher incidence of depression compared to non-obese individuals."

Only a few other diet drugs are on the market in the USA, including one that keeps some dietary fat from being absorbed by the body and another that works on brain chemistry to enhance fullness.

Psychologist Thomas Wadden, an obesity researcher at the University of Pennsylvania School of Medicine in Philadelphia, says the decision is "a big disappointment for the field of obesity medicine. Doctors and their obese patients need new weight-loss medications that are safe and effective."

But note that psych drugs are still on the market.