The Pharmaceutical Journal
Vol 279 No 7462 p93
28 July 2007

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Related websites
European Medicines Agency: Acomplia
• European public assessment report
• Questions and answers (PDF 50K)
• Summary of product characteristics (PDF 250K)

Rimonabant's depression warnings to be upgraded

Rimonabant (Acomplia) should not be prescribed for patients who have major depression or who are being treated with antidepressants because of the risk of exacerbating psychiatric problems, the European Medicines Agency (EMEA) has recommended.

The summary of product characteristics for rimonabant, which is licensed for the treatment of obese or overweight patients, already warns that the drug is not recommended in these patients.

However, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) has advised that the warning be upgraded.

The decision comes after all available information on the psychiatric side effects of rimonabant was assessed by the CHMP as part of its continuous monitoring of medicines. It concluded that the benefits of rimonabant continue to outweigh its risks except in patients with ongoing major depression or in those taking an antidepressant.

The risk of depression is approximately doubled in all patients taking rimonabant but may be even higher in those with a past history of depression. Although this pattern of side effects is similar to what was seen when the drug was first approved, rimonabant is now being used in wider populations, including patients with a history of psychiatric events.

The CHMP also recommends adding a warning that treatment should be stopped if a patient develops depression, as well as including additional information on the drug’s psychiatric safety. Updated prescribing information will be sent to prescribers.

The Medicines and Healthcare products Regulatory Agency has advised that patients who are taking rimonabant and experience depression for more than a few days and those who are also taking antidepressants should consult their doctor. Patients who have previously had depression but feel well on rimonabant should continue their treatment and consult their doctor at their next routine appointment.