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, shopping and having sex.

While the urges are rare, patients–including children–taking Otsuka’s Abilify, Abilify Maintina, 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.

Source – http://www.fiercepharma.com/pharma/abilify-gets-warning-for-binge-eating-sex-urges-added-to-label