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Aripiprazole (Abilify®, Abilify Maintena®) and Aripiprazole Lauroxil (Aristada™) and Impulse Control Issues

May 6, 2016

FDA has received reports of impulse control issues in patients using aripiprazole. These issues include compulsive urges to eat, gamble, shop, and have sex. These urges could result in harm to the patient or others. There are 167 US case reports in the FDA Adverse Event Reporting System for an association between aripiprazole and impulse control issues. This problem can occur in any type of patient group using aripiprazole, including those without baseline compulsive symptoms. Aripiprazole is used to treat many types of psychiatric disorders including bipolar disorder, depression, and schizophrenia. It is available as generic drug products and under the brand names Abilify®, Abilify Maintena®, and Aristada™ (as aripiprazole lauroxil).

The prescribing information for aripiprazole products currently lists pathological gambling as a side effect recognized in postmarketing experience. However, this term does not address the other compulsive behaviors reported. FDA is requiring new warnings in the prescribing information and Medication Guides for aripiprazole products about the other compulsive behaviors.

Health care professionals should educate patients and caregivers of patients using aripiprazole about these impulse control issues. Monitor patients for new or worsening compulsive urges, especially in patients at risk for impulse control issues (eg, history of obsessive-compulsive disorder, addictive behaviors). Consider discontinuing or reducing the dose of aripiprazole in patients who develop impulse control issues. This usually resolves the urges within days to weeks. Advise patients not to discontinue aripiprazole without consulting their prescribing physician.

Additional information:

Updated
May 6, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.