Pharmaceutical News - November 2007

Anti-Obesity Drug Rimonabant Linked to Depression

Posted by Paul Fiddian on 16/11/2007 - 14:57:17

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A new report on the anti-obesity drug rimonabant raises queries about its safety, with a substantial link made between it and mental health problems. The drug in question, which is sold as Acomplia, is available on the UK National Health Service and prescribed to those considered overweight or obese. According to the report, those taking it are 40 per cent more likely to become depressed.

Psychological Problems More Likely in Rimonabant Patients

The research behind the report was undertaken by scientists in Denmark, who studied the records of 4105 patients. They discovered that, while those taking rimonabant lost, on average, 4.7 kilograms more than patients who had been given a placebo, they were also at a significantly higher risk of developing psychological problems.

Rimonabant patients were over twice as likely to end their use of the drug because of depression.

The report is included in the Lancet medical publication. It is accompanied by an editorial prepared by experts in Australia who, commenting on the study, highlight how it "raises major questions about the safety of rimonabant in obese people."

Last year, more than one million patients were prescribed obesity drugs in the UK alone. On the worldwide scale, more than one billion people are considered either obese or overweight.

The Danish research mirrors the findings of the US Food and Drug Administration, which discovered mental health symptoms in more than 25 per cent of those taking rimonabant, compared to just 14 per cent in those prescribed a placebo.

Statistically, said the new report, symptoms of depression were observed in one patient per 49 given the drug. Anxiety, meanwhile, was recorded in one out of 166. Less significant side effects, but related to mental health, were seen in one in 25.

"That obese patients who are prescribed rimonabant in clinical practice are less likely to be screened for depression disorders than the participants in the trials is a matter of concern", the report stressed.

"Consequently, the number needed to harm could be much lower than this finding in clinical practice."

"The findings of our meta-analysis suggest that the potential of rimonabant to induce depressive symptoms and depression in overweight patients needs greater attention", it concluded.

Depression Warning Added by Drug's Maker Sanofi Avensis

Rimonabant's manufacturer, Sanofi Avensis, has amended the drug's labelling to warn against it being prescribed for people who have historically suffered from depression, or who are currently being treated for it.

In a separate study, the actual performance of Rimonabant has been questioned, alongside two other drugs.

Source - Pharmaceutical International's Health Reporter

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