Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
The FDA recently released a Drug Safety Communication concerning aripiprazole, which is found in popular antipsychotic drugs, Abilify, Abilify Maintena, and Aristada. This FDA article warned of possible "compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex" among adults and children taking one of the aforementioned aripiprazole drugs.
This warning was based on the 184 case reports involving these aripiprazole drugs and impulse-control problems, of which 167 occurred in the United States.
According to the reported cases from the past 13 years, pathological gambling was the most common uncontrollable behavior observed, but other impulsive urges -- including compulsive eating, spending or shopping, and sexual behaviors -- were also reported.
Of note, such impulsive behaviors were not previously observed in the patients, and reportedly ceased after the patient stopped taking Abilify, Abilify Maintena, or Aristada, or once they had their dose reduced.
We get this additional information from the Medpage Today article, FDA Warning: Abilify Tied to Impulse Control Problems:
The FDA did not identify a specific mechanism to account for these effects, but it hinted at one: Aripiprazole is unique among atypical antipsychotics in that, whereas others in the class are strong blockers of dopamine receptors in the central nervous system, aripiprazole is only a partial blocker, the agency said.
Though the FDA drug label for Abilify currently lists "pathological gambling" as a possible side effect, the FDA states that "this description does not entirely reflect the nature of the impulse-control risk that [they] identified." Additionally, they "are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products," in order to more adequately warn of such side negative effects.
The FDA further cautions that such uncontrollable behaviors "may result in harm to the patient and others if not recognized." As such, the FDA advises patients and caregivers to "be alert for uncontrollable and excessive urges and behaviors" while taking Abilify, Abilify Maintena, or Aristada. They also state that "patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional."
We will continue to watch for the revised drug labels and Medication Guides for Abilify, Abilify Maintena, and Aristada, and report on any new developments concerning these drugs.
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