FDA Issues Compulsive Behavior Warning for Aripiprazole Products

The FDA is warning that uncontrollable urges to gamble, binge eat, shop, and have sex are associated with the use of the antipsychotic aripiprazole (Abilify, Abilify Maintena, Aristada).

These impulse-control problems reportedly stop when aripiprazole is discontinued or the dose is reduced. Although these associated uncontrollable urges are rare, the FDA has warned that they could result in harm to patients and others if they go recognized.

Since the first aripiprazole product (Abilify) was approved in November 2002, the FDA has identified a total of 167 US cases involving an association between aripiprazole use and impulse-control problems in adults and children. Pathological gambling was the most prevalent (164 cases), but compulsive eating, spending, and sexual behaviors were also reported.

Because the FDA’s Adverse Event Reporting Program only includes reports submitted to the FDA, there may be additional cases of compulsive behavior that the FDA doesn’t know about. For context, pharmacists at US outpatient retail pharmacies dispensed aripiprazole to about 1.6 million patients in 2015 alone.

Pathological gambling was added to aripiprazole’s label as a reported side effect in January 2016, but this description doesn’t entirely reflect the nature of the impulse-control risk that the FDA has identified, and it doesn’t detail other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions.

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

Pharmacists and other health professionals should know that these side effects could affect any patient, regardless of whether or not they have a history of compulsive behavior. Although the side effects were reported to stop when the medication was discontinued or the dose was reduced, patients should be advised against stopping aripiprazole treatment without first consulting with a health care professional.

Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, and irritability associated with autism. It can also be used as a co-treatment for depression.