8213
0
Posted on Oct 24, 2008, 7 a.m.
By Rich Hurd
The European Medicines Agency (EMEA) has advised doctors not to prescribe the anti-obesity drug rimonabant, also known as Acomplia, because of concerns that it causes psychiatric problems.
The European Medicines Agency (EMEA) has advised doctors not to prescribe the anti-obesity drug rimonabant, also known as Acomplia, because of concerns that it causes psychiatric problems.
A news release issued by the regulatory authority states: “The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorization should be suspended across the European Union (EU).” They add: “In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials.”
There have been concerns over the safety of rimonabant ever since it was first approved for use in Europe back in 2006. Last year the EMEA said that it should not be prescribed to patients with a history of major depression, and that doctors must be watchful for symptoms of depression in patients taking the drug. In fact, recent study data, including data from the manufacturer Sanofi-Aventis, has shown that the drug doubles the risk of psychiatric disorders. It has also been linked to an increased risk of suicide.
The EMEA has told doctors not to issue any prescriptions for Acomplia, and to review the treatment of patients currently taking the drug. They also advised patients who are currently taking Acomplia to consult their doctor or pharmacist at a “convenient time”.
Acomplia is not available in the US. The Food and Drug Administration (FDA) decided not to approve the drug because of concerns over its safety.
News release: The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia. European Medicines Agency Website. October 24th 2008.
