May 3, 2016 — The FDA has issued a Safety Communication to warn about the risk of uncontrollable urges to gamble, binge eat, shop, and have sex with the use of Abilify (aripiprazole).

The FDA identified 184 case reports of impulse-control problems since Abilify was approved in November 2002.

Pathological gambling was the most common (164 cases), but compulsive eating, spending or shopping, and sexual behaviors were also reported.

In most cases, patients with no history of compulsive behaviors experienced uncontrollable urges after starting Abilify. These urges stopped within days or weeks of discontinuing Abilify or reducing the dose.

Warnings about compulsive gambling are currently on the label for Abilify. However, the FDA is concerned that the label does not adequately warn about other impulse-control disorders, which can affect anyone taking the medication.

As a result, the FDA is updating the label. Healthcare professionals should warn patients about the risk and ask them about any new or increasing urges. This is especially important for patients with risk-factors, such as a personal or family history of:

  • Obsessive-compulsive disorder
  • Bipolar disorder
  • Impulsive personality
  • Alcoholism
  • Drug abuse
  • Other addictive behaviors

Abilify is an anti-psychotic drug in the dopamine receptor agonist class. It is used to treat schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autism. It may also be used in combination with antidepressants to treat depression.

Evidence linking Abilify and impulse-control problems has been growing since 2009, when a small study by researchers at the Mayo Clinic found high rates of compulsive syndromes. In October 2014, JAMA Internal Medicine confirmed the risk and recommended a “Black Box” warning.


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