Fait Acomplia? New Study Lends Weight to FDA Concerns
An anti-obesity drug carries an increased risk of depression and anxiety.
Nov. 15, 2007— -- Obese patients taking the weight-loss drug rimonabant — also known as Acomplia — have an increased risk of developing severe depression and anxiety, a new study reports.
The study confirms similar findings by the Food and Drug Administration on rimonabant earlier this year — findings that led an FDA advisory panel to recommend against marketing approval of the appetite suppressant in the United States in June.
In addition to a potential risk of depression and anxiety, the FDA also found an increased chance of irritability, insomnia, panic attacks, aggression and suicide in patients taking the diet pill. Several patients taking rimonabant were prescribed antidepressants or tranquillizers to keep their symptoms under control.
Before the decision, pharmaceutical giant Sanofi-Aventis had intended to sell rimonabant under the brand name Zimulti in the United States. Currently, rimonabant is available in several European countries under the Acomplia brand name.
The study was published Thursday in the medical journal Lancet. Researchers at the University of Copenhagen looked at data gathered from four previous studies.
The analysis showed that the drug was effective. Patients taking rimonabant, on average, lost 4.7 kilograms — 10.3 pounds — more weight after one year than did patients who, instead, took a placebo.
But the study also found that patients taking rimonabant were at risk for adverse psychiatric events — specifically, depressed mood disorders and anxiety.
The psychiatric side effects of the diet pill were apparent in some patients, even though all these studies excluded those who had existing psychiatric problems.
What this means is that the potential side effects of rimonabant could be especially dangerous to those in the general population who already have underlying psychological illnesses.
"The increased risk of depression and anxiety is certainly concerning, especially since the authors excluded patients with pre-existing depression," said David Kroll, pharmacologist and adjunct associate professor of medicine at Duke University Medical Center.
