Anti-obesity drug benefits 'no longer outweigh risks'

Acomplia's European marketing authorisation for obese and overweight people has been suspended by the European Medicines Agency (EMEA).

The EMEA said it has decided that the benefits of rimonabant, which is marketed in Europe as Acomplia, no longer outweigh its risks. Prescribers should not issue any prescriptions for Acomplia and should review the treatment of patients currently taking the medicine, the EMEA said.

There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time, the EMEA advised. Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment.

Acomplia's manufacturer Sanofi-Aventis said that it was complying with the EMEA’s recommendation.

‘Sanofi-Aventis is committed to provide additional evidence for the re-evaluation of the benefit/risk profile of Acomplia in patients with diabetes and cardiovascular disease through the ongoing clinical studies,’ the company said in a statement.

‘Sanofi-Aventis remains committed to Acomplia to bring an important therapeutic approach to obese and overweight patients.’

The EMEA said it had assessed the benefits and risks of Acomplia, including data from studies completed since the drug was licensed. These showed an increased risk of psychiatric disorders patients taking Acomplia.

The EMEA said it believed that these side effects could not be adequately addressed by risk minimisation measures.

In addition, the agency said that the effectiveness of Acomplia in clinical practice had been found to be 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.

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