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FDA Warns of Abilify Impulse Control/Binge Problems


On May 3, 2016, the 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 FDA identified. In addition, FDA has 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 all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

 

Aripiprazole 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. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder. Aripiprazole is an atypical antipsychotic; however, it works somewhat differently than the other medicines in its drug class. Most atypical antipsychotics more fully block dopamine receptors in the brain, while aripiprazole only partially blocks the activity of these receptors.

 

In 2015, approximately 7.7 million prescriptions for oral aripiprazole were dispensed and approximately 1.6 million patients received a dispensed prescription for oral aripiprazole from U.S. outpatient retail pharmacies.

 

A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature in the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002 identified a total of 184 case reports in which there was an association between aripiprazole use and impulse-control problems. There were 167 U.S. cases, which included adults and children. 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, so there may be additional cases about which FAERS is unaware. In order to provide context for these drug-associated events, approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies during 2015.

 

In the majority of cases, patients with no prior history of the compulsive behaviors experienced uncontrollable urges only after starting aripiprazole treatment. Within days to weeks of reducing the dose or discontinuing aripiprazole, these uncontrollable urges stopped.

 

See the FDA Safety Alert

 

See the FDA Drug Safety Communication

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication 

 

 

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