One of the most top selling antipsychotic drugs in the United States, Abilify has recently received FDA (Food and Drug Administration) warnings. The FDA safety announcement was released on Tuesday, May 3rd, with a report of “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”
According to the FDA, granting that these compulsive urges are “rare,” they can impose harm to patients or others if not sighted. Abilify is also sold under the generic name aripiprazole and the brand names of Abilify Maintena and Aristada.
What is Abilify?
Abilify is an atypical antipsychotic drug manufactured by Bristol-Myers Squibb and Otsuka Pharmaceuticals. It is used to treat symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression), Tourette’s disorder, and irritability associated with autistic disorder, and it works by helping to restore the balance of certain natural chemicals in the brain.
Apparently, in its attempt to restore the balance of neurotransmitters in the brain, Abilify releases additional influence on dopamine serotonin receptors. Now, these dopamine receptors are responsible for the central role of pleasure and motivation in the brain. Therefore, large amounts of dopamine can allegedly influence compulsive behaviors such as gambling. The FDA alleged that in most cases, patients who had no previous history of compulsive behaviors encountered uncontrollable urges solely after starting aripiprazole (Abilify) treatment.
Moreover, the uncontrollable urges ceased within days to weeks of discontinuing Abilify or after the dose being reduced. The drug was first approved by the FDA in November of 2002. Now in the 15 years that Abilify was on the market, the FDA received reports of impulse control approximately 184 times. In 2015 alone, 1.6 million prescriptions were given by the U.S. outpatient retail pharmacies per the FDA.
The agency also stated that despite the fact that pathological gambling is listed as a reported side effect in the prescribing labels of Abilify, this description does not undividedly echo the essence of the impulse-control risk that were identified. So, did the makers of Abilify fail to warn its consumers or provide prescribing labels for the side effects of compulsive gambling? I’d say it’s something to consider.
The FDA addressed its warnings to patients, caregivers, and healthcare professionals, prompting them to be “aware and alert” about the risks of uncontrollable behaviors, and to talk to a professional if such side effects are seen.