JAMA has published a letter that has raised safety concerns with respect to the rates of psychiatric disorders in those patients who received diet aid Acomplia (rimonobant) compared to those who received placebo in the drug's clinical trials, including the RIO study .
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 adverse events as "common" (occurring at rates between 1% and 10%), these are:
Depressive disorders
Mood alterations with depressive symptoms
Anxiety
Irritability
Nervousness
Sleep disorders
Insomnia
Parasomnias
Hat tip: Prescribing advice for GP's
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