The U.S. Food and Drug Administration is warning that uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada and generics).
These uncontrollable urges stopped when the medicine was discontinued or the dose was reduced.
Current drug labels do not entirely show the nature of the impulse-control risk. “These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products,” the FDA says.
Litigation is active against manufacturers Bristol-Myers Squibb, Otsuka Pharmaceutical Co., Ltd., and Otsuka America Pharmaceutical, Inc. In a case filed by Denise and Brad Miley in federal court in Minnesota, CASE 0:16-cv-00067, Denise Miley took Abilify and as a result developed compulsive gambling behaviors. She began taking Abilify in September 2014, began compulsively gambling shortly thereafter, and stopped gambling soon after she stopped taking the drug.
The drug companies do not warn Abilify users or prescribers in the United States about the risk of compulsive gambling or other compulsive behaviors.
Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are taking aripiprazole. “Closely monitor patients with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors,” the FDA said.
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.
184 reports of impulse-control problems
In the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002, the FDA identified a total of 184 case reports where 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.
Approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies during 2015.
“We strongly advise health care professionals, patients, and caregivers to report side effects involving aripiprazole (Abilify, Abilify Maintena, Aristada) and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page,” the FDA said.