FDA Warning: Antipsychotic Linked to Impulse-Control Problems
The FDA has mandated new warnings to include a list of compulsive behaviors.
The Food and Drug Administration (FDA) issued a warning that the use of aripiprazole has been linked to compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex. These impulse-control problems were reported to have ended upon discontinuing the medication or reducing the dose.
Aripiprazole, an atypical antipsychotic, is marketed as brand name Abilify (Otsuka), Abilify Maintena (Otsuka), Aristada (Alkermes), as well as generic products. It is indicated for the treatment of certain psychiatric disorders, including schizophrenia, bipolar disorder, Tourette's, and irritability associated with autistic disorder. It is sometimes used with antidepressants to treat depression.
Currently, pathological gambling is mentioned as a reported adverse event in aripiprazole drug labels but it does not encompass the full nature of the impulse-control risk that the FDA has identified nor does it include the other compulsive behaviors associated with aripiprazole use. The FDA warned that the impulsive behaviors, though rare, may cause harm to the patient or others if not identified. The FDA is requiring the addition of new warnings to include all of these compulsive behaviors in the drug labels and Medication Guides for all aripiprazole drugs.
The FDA Adverse Event Reporting System (FAERS) database and literature searches returned a total of 184 case reports where there was an association between the use of aripiprazole and impulse-control problems. The most common problem was pathological gambling, which was cited in 164 cases. Other compulsive behaviors included compulsive sexual behaviors (n=9), spending/shopping (n=4), multiple impulse-control problems (n=4), and compulsive eating (n=3). In all of the 167 FAERS cases, patients experienced the new urges only after initiating treatment with aripiprazole but the urges resolved after reducing the dose or discontinuing treatment; none of the patients had concurrent substance abuse disorders, manic symptoms or a history of the said compulsive behaviors. Four of the cases found in medical literature reported a return of compulsive behaviors when aripiprazole was restarted.
Healthcare professionals should inform patients and caregivers about the risk of these impulse-control behaviors when prescribing, and also ask about any new or increasing urges during treatment with aripiprazole. Patients at higher risk for impulse-control problems 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. If such urges arise, clinicians should consider dose reduction or discontinuing the medication.
Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems. FDA. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498823.htm. Accessed May 6, 2016.