European regulators to re-examine rimonabant
According to several news sites, including the BBC and PharmaTimes, the European Medicines Agency (EMEA) will review the safety of rimonabant (Acomplia®) next week following the drugs rejection by the FDA, as reported yesterday.
Several of these stories have highlighted the fears about suicide identified by the FDA. This coverage is likely to increase the number of queries from patients already on treatment.
Action: Until the EMEA clarify the European position, it would seem prudent to suspend use of rimonabant in new patients. Patients who are already taking rimonabant and who are concerned about the safety of rimonabant should have treatment stopped and be changed to an alternative therapy if appropriate.
« FDA reject rimonabant | NRT works in the "real world" » |
[…] in patients taking antidepressants or those with major depression. This announcement follows the EMEA review of the safety of this […]
Pingback by MHRA advice on rimonabant | Prescribing Advice for GPs — July 20, 2007 #