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Regulatory Focus™ > News Articles > Antipsychotic Label Updated With New Impulse-Control Side Effects

Antipsychotic Label Updated With New Impulse-Control Side Effects

Posted 03 May 2016

Antipsychotic Label Updated With New Impulse-Control Side Effects

The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals.

“These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced,” FDA says. “These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.”

Pathological gambling is currently listed as a reported side effect on the aripiprazole labels, though FDA says the current label “does not entirely reflect the nature of the impulse-control risk that we identified. In addition, 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 who is taking the medicine.”

As a result, FDA is adding new warnings about these compulsive behaviors to the drug labels and the patient medication guides for all aripiprazole products.

FDA says patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole.

Aripiprazole, generics of which were approved by FDA in 2015, is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking.

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

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