Abilify- FDA warns about new impulse-control problems associated with mental health drug aripiprazole.

impulse-control-previewThe U.S. Food and Drug Administration (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, but they may result in harm to the patient and others if not recognized.

Aripiprazole:

  • Aripiprazole is used to treat certain mental disorders, such as 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.
  • Aripiprazole is available under the brand names Abilify, Abilify Maintena, Aristada, and also as generics.
  • Common side effects of aripiprazole include dizziness, lightheadedness, drowsiness, excess saliva/drooling, blurred vision, weight gain, constipation, feeling the urge to move constantly, and trouble sleeping.

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 we identified. In addition,there are 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 has added new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

What patients should do?

  • Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole.
  • It is important to talk with a health care professional as soon as possible if you 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.

What Health care professionals should do?

  • 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 being treated with aripiprazole.
  • 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. Consider reducing the dose or stopping the medicine if such urges develop.
  • Consider lowering the dose or stopping aripiprazole if a patient develops new or increased impulsive or compulsive behaviors.
  • Encourage patients to read the patient Medication Guide they receive with their aripiprazole prescriptions.

Reference;

FDA  Warning