Concerned by the Lancet report and a similar report that appeared this week in the British Medical Journal, Acomplia’s manufacturer Sanofi-aventis leaped out a statement on Nov.16th responding to the stories.

In a study published in the Nov. 17 edition of The Lancet, the researchers concluded, "Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events—i.e., depressed mood disorders and anxiety— despite depressed mood being an exclusion criterion in these trials."

In response to the study published, Sanofi statement said, "The meta-analyses published in the Lancet and BMJ reflect the data previously published, and do not introduce any new information that doctors, Sanofi-Aventis and regulatory bodies have not already considered and acted upon. The articles summarise the recognized benefits of Acomplia on weight and multiple risk factors, including glycaemic control in those with diabetes.

The authors also report the well established side effect profile, including the psychiatric events that are already appreciated by clinicians who prescribe the product. They highlighted that it is important to understand that patients who have been depressed are at risk from further episodes, and should therefore not be prescribed this product.

The drug Acomplia has already been denied approval in the U.S. because of the increased suicide risk. However, since the launch of Acomplia, sanofi-aventis has worked closely to monitor safety, and in conjunction with clinicians and regulatory agencies has actively sought to ensure that treatment is prescribed to the right patient.

Sanofi further suggests that this drug is not prescribed for those patients who have severe depression or undergoing anti-depressive treatment.