One of the potential side effects listed for the antipsychotic Abilify and its generics is an uncontrollable urge to gamble. But the FDA is now saying that does not nearly encompass the uncontrolled impulses the drug can inflame. And so it is now warning about pathological urges to binge eat, shop or have sex.
While the urges are rare, patients–including children–taking Otsuka’s Abilify or Abilify Maintina, or Alkerme’s Aristada or any aripiprazole generic should be watched by caregivers or doctors “in order to prevent or limit possible harm,” the FDA said in a warning issued Tuesday. The FDA said the urges will cease if the drug is stopped, but it also warns that patients exhibiting the urges should talk with a doctor before stopping the drug.
The agency said that in 13 years of results from its FDA Adverse Event Reporting System (FAERS) database, it uncovered 184 case reports tying aripiprazole use and impulse-control problems, 167 in the U.S. It said 164 cases were for uncontrollable gambling but the other urges to eat, shop and have sex were also reported. There were 1.6 million people taking aripiprazole in 2015.
Other drugs have been associated with the same kinds of urges and a study in 2014 said the urges are not rare at all. Try 10% of patients. Thomas Moore of the Institute of Safe Medication Practices and a lead author said the side effects are under-reported because people don’t want to tell doctors about these kinds of behaviors.
“If you compare that with, say, the risk of suicide among patients who take antidepressant drugs, this is much higher. It’s an astronomical rate, in terms of adverse event risk,” Moore said at the time.
Some patients have been willing to confess the urges to lawyers. Boehringer Ingelheim was sued by a New York man some years back who said that taking the drug had turned him into a “pathological gambler,” ruining him as he gambled away $3 million. Last year Pfizer ($PFE) settled a class-action lawsuit with 172 people in Australia who had reported similar urges after taking Pfizer’s Cabaser and Dostinex to treat tremors associated with Parkinson’s disease or restless leg syndrome.
May 4, 2016