Health Canada issues safety alert on Abilify

3 November 2015

Labels for the prescription antipsychotic drugs Abilify and Abilify Maintena (aripiprazole) have been updated to advise of an increased risk of impulsive behaviors of pathological gambling and hypersexuality, said pharma regulatory agency Health Canada on Monday.

The two brands are marketed by US pharma major Bristol-Myers Squibb (NYSE: BMY) and Japanese drugmaker Otsuka Pharmaceutical’s (TYO: 4768). However, the patent on Abilify has now expired and the brand is exposed to generic competition.

Abilify, a tablet taken by mouth, is authorized to treat a certain type of bipolar disorder (bipolar 1, a serious manic-depressive illness involving extreme manic or mixed episodes) in adults and adolescents aged 13 years and older. It is also authorized to treat schizophrenia and related severe psychotic disorders in patients aged 15 years and older, and major depressive disorder in adults when used in combination with other drugs. Abilify Maintena is an injectable drug administered by health professionals and is used to treat schizophrenia in adults.

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