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FDA Issues Warning Regarding Abilify and Compulsive Gambling

On May 3, 2016, the FDA required that a warning be added to the Abilify label directing patients and caregivers to monitor experiences of uncontrollable behavior, such as compulsive gambling while taking Abilify. The announcement reads…

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. 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, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

The warning also specifies that doctors must notify patients of these additional risks and specifically ask about any new or increasing urges while they are being treated with the drug. Read more below.

MAY 3, 2016 FDA ABILIFY WARNING

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