The move comes after the European Medicines Agency noted that a study revealed obese or overweight patients taking the fat pill faced approximately double the risk of developing psychiatric disorders than patients taking a placebo.

The drugmaker will “immediately” start talks with countries outside the European Union where Acomplia is sold to suspend sales there as well, according to a statement. The pill has been sold in 18 EU countries for two years. (Listen to the conference call).

According to the EMEA, “new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine,” and that “these psychiatric side effects could not be adequately addressed by further risk minimisation measures…In addition, the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period.” (Back story).

Despite the setback, Sanofi-Aventis says it is “committed to provide additional evidence for the re-evaluation of the benefit/risk profile of Acomplia,” which is used to treat patients with diabetes and cardiovascular disease. Such benefits failed to convince the FDA, which last year refused to approve its use after reviewing studies showing a risk of suicidal behavior (look here).