Abilify is an antipsychotic medication that increases dopamine, a chemical in the brain that is released during pleasurable activities. It reinforces behaviors as part of the brain’s “reward system.”

Dozens of lawsuits claim drug-makers knew about the risk of uncontrollable urges and failed to warn patients or doctors.

The urges typically began soon after patients started taking Abilify or increased their dose. In some cases — though not all — the intense urges ended abruptly when they stopped taking Abilify.

Warnings about gambling addiction were added to labels in Europe and Canada several years ago, but the word “gambling” did not appear on labels in the United States until 2015.

The new label includes the following warning about pathological gambling and other compulsive behaviors:

Post-marketing case reports suggest that 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. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development or new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with [Abilify]. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.”

Source: FDA Drug Safety Communication

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