Psychiatric side effects of Sanofi-Aventis obesity drug

A new obesity drug by Sanofi-Aventis is under a scan after the reports of it being linked to psychiatric side effects were released.

The results of two studies reveal that drug induces weight-loss pointing to severe psychiatric side effects.

Sanofi-Aventis is the third largest pharmaceutical company in the world. Earlier this year, it had to withdraw its application for the approval for the market launch of obesity drug Acomplia in the US following the rejection by FDA over its side effects.

The company was planning to again submit the application on the basis of the clinical trial reports but now the reports have confirmed its psychiatric side effects. A lawsuit has been filed against the company in the U.S. for misleading the people by using incorrect statements about the drug.

The studies noted that Acomplia "increased the risk of mood disorders such as depression or anxiety" and also questioned its long term effects of its anti-obesity treatment. Sanofi-Aventis's Acomplia was one of the three drugs tested for the side effects. It "increases the risk of psychiatric events - i.e. depressed mood disorders and anxiety."

Sanofi-Aventis spokesman said the company "believes that the meta-analyses do not reveal new objective data given what is already known by the medical communities and the Health authorities."

"The authors' cautiousness are in line with the efforts made by the company to ensure that Rimonabant - Acomplia - benefits to the patients suffering from obesity and associated cardiovascular risk factors, excluding patients with severe depression or patients treated by an anti-depressive event." he added. In a press release later the company said, the reports are only the interpretation of the author.

Stocks of the company have been fallen by 17% since the rejection. Shares were trading lower by 0.3 or 0.5% at EUR60.00 on Thursday. Traders feel that the share prices will fall further as class-action lawsuit was launched in the U.S. and misleading statements are being spread in the market. The suit claims the French drug company concealed data concerning Zimulti's propensity to cause depression.

Sanofi spokesman said that, “after a comprehensive review of all clinical data, EMEA recently confirmed the favorable risk-benefit profile of Rimonabant - Acomplia - except in patients with ongoing depression or patients treated by an anti-depressive agent."

Sanofi-Aventis's head of pharmaceutical operations, Hanspeter Spek, said "within the current environment, the product will only see marginal progress." Acomplia reached sales of EUR21 million in the third quarter and EUR58 million to the end of September in 21 countries outside US where it is being marketed.

The company’s next venture is to submit Acomplia as a worldwide medicine in 2009 for the treatment of diabetes. According to the company sources, European Commission endorsed the positive opinion of the European Medicines Evaluation Agency for Acomplia to include type 2 diabetes trial results into the European label.