The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of rimonabant no longer outweigh its risks and the marketing authorisation should be suspended across the EU.
Following the assessment of the available information on the benefits and risks of rimonabant including data from studies completed since it was granted marketing authorisation, the CHMP confirmed at its October 20-23 meeting, that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared with those taking placebo.
The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side effects could not be adequately addressed by further risk minimisation measures.
In addition, the CHMP noted, that the effectiveness of rimonabant in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take rimonabant only for a short period.
Prescribers should not issue any prescriptions for rimonabant and should review the treatment of patients currently taking the medicine. There is no need for patients to stop treatment with rimonabant immediately, but patients who wish to stop can do so at any time.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU countries.
Source: Doc Guide