The Journal of the American Medical Association has published a letter that has raised safety concerns with respect to the rates of psychiatric disorders in those patients who received rimonobant (Acomplia®) compared to those who received placebo in the published studies.
In reply to this letter the authors of the study point out that patients were not excluded from the study based upon an abnormal score on the Hospital Anxiety and Depression scale (scores of above 7). Patients with serious uncontrolled psychiatric illness were excluded for the study including those with major uncontrolled depression.
The Summary of Product Characteristics recommends that rimonobant should not be used in patients who are taking antidepressants. It also lists several psychiatric disorders as common (occurring at rates between 1% and 10%), these are:
- Depressive disorders
- Mood alterations with depressive symptoms
- Sleep disorders
Action: As already suggested, rimonobant is the fourth line choice after existing treatment options. Patients should be warned about psychiatric side effects and treatment stopped should they occur.
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