Diet Drug Rimonabant Tied to Depression, Anxiety

Experts caution against prescribing drug to patients who are already depressed

By Steven Reinberg
HealthDay Reporter

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THURSDAY, Nov. 15 (HealthDay News) -- People who take the weight-loss drug rimonabant may face heightened risks for severe depression and anxiety, Danish researchers report.

The finding follows a recommendation by a U.S. Food and Drug Administration panel in June that the agency not approve the diet drug because of continuing concerns about increased risks for suicidal thoughts among some users. Previously, the FDA rejected the drug as an aid to help people quit smoking.

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"Up to this point in time, there has been controversy over the rates and severity of psychiatric adverse effects with rimonabant," noted Dr. Philip Mitchell, head of the School of Psychiatry at the University of New South Wales in Sydney, Australia, and co-author of an editorial that accompanies the study.

This is the first review to examine rates of severe psychiatric symptoms with rimonabant (Acomplia), symptoms severe enough that patients discontinue treatment, Mitchell said.

The report is published in the Nov. 17 edition of The Lancet.

In the meta-analysis, Dr. Arne Astrup, from the department of human nutrition at the University of Copenhagen, collected data on more than 4,100 patients enrolled in four clinical trials. Those trials compared taking rimonabant (20 milligrams a day) against a placebo.

The researchers found that people taking rimonabant did lose weight -- about 15 pounds in a year -- compared to those receiving a placebo.

However, those taking rimonabant were also 40 percent more likely to have an adverse reaction than people not taking it. In fact, those taking rimonabant were 2.5 times more likely to stop taking the drug because of depression and three times more likely to stop the drug because of anxiety, compared to people on placebo.

"Our findings suggest that 20 milligrams per day of rimonabant increases the risk of psychiatric events -- i.e., depressed mood disorders and anxiety -- despite depressed mood being an exclusion criterion in these trials," Astrup's team said. "Taken together with the recent U.S. Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions."

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