A European health watchdog has warned that taking weight-loss drug Acomplia bears a risk of developing psychiatric side effects.

The European Medicines Agency (EMEA) recommended this week for a stronger warning on weight-loss drug Acomplia, from Sanofi-Aventis, after it was linked to an increased suicide risk.

The product seems to be contraindicated for patients with ongoing major depression and/or taking antidepressants.

EMEA said doctors in the European Union have already been warned about his possible risk, since June 2006. The agency’s Committee for Medicinal Products for Human Use (CHMP) has now recommended upgrading this warning.

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.

Sanofi did not receive approval from the Food and Drug Administration to release Acomplia in the US. Last month, the company relinquished its new drug application.

A statement posted by Sanofi-Aventis on its official website says the drug’s labeling was updated based on observations of Acomplia’s effects during its past year of marketing, especially in Germany, the UK and France.

This was coupled with clinical trials completed after the June 2006 approval.

The statement adds that Acomplia, generically known as Rimonabant, has been successful during clinical trials in treating obese or overweight patients: it significantly reduced body weight and waist circumference, the statement says.

Aside from the psychiatric disorders, other side effects observed in patients taking Rimonabant were nausea, vomiting, headaches and dizziness.