WASHINGTON -- The atypical antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada) may trigger loss of impulse control, leading to "compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex," .
New warnings will be added to labels and patient medication guides for aripiprazole products.
The FDA noted that compulsive gambling was already included on the products' labels as a known adverse effect, but event reports submitted to the agency point to a wider variety of impulse-control problems. These are similar to those previously seen with dopamine agonist drugs used in Parkinson's disease such as pramipexole (Mirapex) and rotigotine (Neupro).
A search of the published literature and the agency's adverse event database yielded 184 reports of impulse-control problems associated with aripiprazole (167 in U.S. patients). Pathological gambling was the most common, the FDA said, but reports also told of compulsive spending, shopping, and eating, as well as hypersexual behavior.
In most cases, these behaviors had not previously been noted in the patients, and they resolved after stopping the drug.
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.
Also noted was that the 184 reports spanned the 13-year history of the drug's availability; in 2015 alone, the agency said, some 1.6 million people filled a prescription for aripiprazole at retail pharmacies.
The FDA recommended that physicians discuss these newly recognized risks with patients and caregivers, and that providers should quiz patients about "any new or increasing urges" while taking the drug.
Aripiprazole products are approved for schizophrenia, bipolar disorder, Tourette syndrome, and irritability in autistic disorders, and for depression in combination with traditional antidepressants.