atients taking the antipsychotic drug Abilify, one of the country’s top-selling prescription medications, have reported uncontrollable urges to gamble, binge eat, shop, and have sex, the US Food and Drug Administration said in a warning Tuesday.
The drug, also known as aripiprazole, is used to treat schizophrenia, and can be used in combination with other drugs to treat depression.
The problem appears quite rarely. In the 13 years since the drug was approved, there have been only 167 reports of patients experiencing significant impulse-control problems, the FDA said. In the United States, 1.6 million patients received Abilify prescriptions last year.
“We decided that a warning would be warranted,” said Sandy Walsh, a spokesperson for the FDA.
The warning comes amid pending class-action lawsuits against the drug’s manufacturer, Otsuka America Pharmaceutical, which allege that the company didn’t properly warn patients about the possible impulse-control issues. Otsuka partners with Bristol-Myers Squibb to manufacture the drug.
Compulsive gambling was previously listed as a side effect on the drug labels, and was the most common side effect seen in the reports filed to the FDA. But excessive shopping, compulsive eating, and an uncontrollable urge to have sex were also reported in a handful of cases. Other serious side effects of the drug: a higher chance of developing diabetes and hyperglycemia, as well as an increased risk of suicide among patients under the age of 24.
The FDA said patients should keep a close eye on excessive urges they might experience while taking Abilify. Walsh added that the agency will add new warnings about compulsive behaviors to both the drug labels and the medication guides given to patients.