August 24, 2016 — Warning labels on Abilify have been updated about the risk of addictive gambling and other uncontrollable behaviors.
Patients may not be able to recognize their compulsive behaviors are unusual, according to the new label (PDF).
Therefore, doctors should specifically ask patients on Abilify about any new or intense urges to gamble, shop, eat, or have sex.
Patients who develop impulse-control disorders should discontinue taking Abilify or reduce their dose. This has been shown to stop the urges in most cases — but not all.
The new warning label states:
Patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking [Abilify]. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.”
In May 2016, the FDA issued a Safety Communication after receiving nearly 200 reports of addictive behaviors in patients on Abilify.
Abilify belongs to a class of drugs called dopamine receptor agonists, which influence levels of dopamine in the brain. Dopamine is a neurotransmitter involved in the “reward system” and feelings of motivation and pleasure.
Bristol-Myers Squibb, the manufacturer of Abilify, is facing dozens of lawsuits from people who say they were not adequately warned about addictive behaviors. A panel of federal judges meet next month to decide whether to consolidate the cases in a Multi-District Litigation (MDL).
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