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FDA Warns of Compulsive Urges with Aripiprazole
The FDA is warning 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, the agency says, 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 that the FDA identified. In addition, the agency said, it 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, the FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.
Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important for patients to talk with a health care professional as soon as possible if they or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm. Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.
Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole. Providers should specifically ask patients about any new or increasing urges while they are being treated with aripiprazole.
In addition, health care professionals should closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. Providers should consider reducing the dose or stopping the medicine if such urges develop.
Aripiprazole is used to treat 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. Approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies during 2015.
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 were also reported, including compulsive sexual behavior (n = 9); compulsive buying (n = 4); compulsive eating (n = 3); and multiple impulse-control problems (n = 4). FAERS includes only reports submitted to the FDA, so there may be additional cases.
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.
The FDA advised health care professionals, patients, and caregivers to report side effects involving aripiprazole to the FDA MedWatch program.
Source: FDA; May 3, 2016.