Warnings about Sanofi-Aventis’ anti-obesity rimonabant (Acomplia) had always accompanied the drug, but the European Medicines Agency announced that the risk of serious psychiatric disorders and even suicide are too high. The European Medicines Agency recommended pulling the drug from the market because of its side effects.

The agency had concluded that “the benefits of Acomplia no longer outweigh its risk” and there was an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia versus a placebo.

Patients taking the drug should consult their doctor, but do not need to immediately stop taking the medication.

In July 2007, the EMEA warned the drug may be unsafe for patients also taking anti-depressants. The agency recommended for a stronger warning on weight-loss drug Acomplia after it was linked to an increased suicide risk. Aside from the psychiatric disorders, other side effects observed in patients taking Rimonabant were nausea, vomiting, headaches and dizziness. The company released a statement saying that the drug’s labelling was updated based on observations of Acomplia’s effects during its past year of marketing, especially in Germany, the UK and France.

The drug has been available in the EU since June 2006 as an adjunct to dieting and exercise for the treatment of obese or overweight adult patients.

Studies made in 2007 confirmed the Food and Drug Adminstration’s concerns on the anti-obesity drug side effects. According to the studies, not only does the obesity drug increase the risk of depressed mood disorders and anxiety, but it is also almost ineffective against obesity, as people lose less than 5 percent of their total body weight.

But data from recent studies has shown the side effects were even higher. Between June and August 2008 there were five suicides among participants in the trial who took the drug, compared to one among those taking a placebo.

The EMEA's Committee for Medicinal Products for Human Use also said the drug was less effective in reality than in the company’s clinical trials.

“Prescribers should not issue any prescription for Acomplia (rimonabant) and should review the treatment of patients currently taking the medicine,” the EMEA said in a statement.

In a statement, Sanofi-Aventis said it would comply with the EMEA’s decision, but reiterated its belief that the drug could bring significant benefits to obese and overweight people. The company said it would reapply to the FDA in the second half of 2009 for approval to treat diabetes. The drug is being tested for Type 2 diabetes. The company says it plans to continue with late-stage Phase III trials of the drug as a treatment for type 2 diabetes in studies involving thousands of patients.

Earlier this month, another anti-obesity drug was rejected by the Food and Drug Adminstration. Merck & Co. announced its decision to cancel further investigation into its experimental obesity drug called taranabant because of side effects uncovered in clinical trials. The side effects associated with the drug taranabant were psychiatric, including anxiety and depression. The experimental therapy was in a phase III clinical trial and just one step away from being submitted for regulatory approval.