Study warns on safety of Sanofi's Acomplia

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. They also found that while patients given Sanofi's drug lost nearly 5 kilograms more over a one-year period, the risk of serious side effects -- ranging from dry mouth to headaches to depression -- rose 40 percent.

Steve - thanks goodness the powers that be have come to their senses regarding this drug. Five years ago, it is very likely that this drug would have received approval in the US. For more, see what we wrote about this drug back in April.