Drugs

FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

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Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin Advanced Practice Nurse from the Division of Drug Information.

On May 3, 2016, FDA warned that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. Additionally, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone taking the medicine. We are adding new warnings about these compulsive behaviors to the drug labels and patient Medication Guides for aripiprazole products.

Health care professionals should inform patients and caregivers of the risk of these uncontrollable urges and ask patients about any new or increasing urges. Closely monitor for new or worsening uncontrollable urges in patients at higher risk. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. Consider reducing the dose or stopping the medicine if such urges develop.

A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature since the approval of Abilify in November 2002 identified 184 case reports in which there was an association between aripiprazole use and impulse-control problems. Pathological gambling was the most common (164 cases), but other compulsive behaviors including compulsive eating, spending or shopping, and sexual behaviors were also reported. FAERS includes only reports submitted to FDA. There may be additional cases about which we are unaware. Approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies in 2015.

Side effects involving aripiprazole should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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Page Last Updated: 05/06/2016
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