Study warns on safety of Sanofi's Acomplia

By Michael Kahn

LONDON (Reuters) - Patients taking the Sanofi-Aventis anti-obesity drug Acomplia have well over double the risk of depression and anxiety, researchers said, adding to the bad news for a drug already linked to suicidal thoughts.

Danish researchers reviewed four studies featuring 4,105 patients and found that people taking 20 milligrams per day of the drug were 2.5 times more likely to discontinue treatment due to depressive disorders and three times more likely to stop because of anxiety than those who received a placebo.

The findings published in the Lancet journal follow a U.S. advisory panel decision in June that the drug should not be approved in the world's largest drugs market because it may increase suicidal thoughts and depression.

"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 reactions," Arne Astrup of the University of Copenhagen and colleagues wrote.

A study in the British Medical Journal on Friday also found that people taking anti-obesity drugs -- including Acomplia -- would only see "modest" weight loss with many remaining significantly obese or overweight.

Salah Mahyahou, Sanofi's head of product communication, said caution raised about who should get Acomplia was in line with the firm's efforts' to ensure the medicine is not prescribed to patients with severe depression or on anti-depressive treatment.

"We believe the meta analysis does not reveal any new data or any new evidence beyond what is already known by physicians or health authorities," he said by telephone.

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