FDA Updates Abilify Label to Include Compulsive Behaviors

The U.S. Food and Drug Administration (FDA) has updated the warning label on Abilify, Abilify Maintena, Aristada and generic aripiprazole to include information about compulsive behavior. According to the safety announcement, there have been reports of uncontrollable urges to gamble, binge eat, shop and have sex in patients taking these drugs. According to the FDA announcement, the compulsive behaviors generally stopped when the dosage was lowered or drug discontinued.

The current label included pathological gambling as a reported side effect, but the FDA stated that this was not an accurate description of impulse-control problems identified. Additionally, the label did not include information about compulsive behaviors other than gambling. As a result, the agency is updating the warning label.

The FDA approved Abilify, the first aripiprazole drug, in November 2002. Since then, 184 cases of impulse-control problems were submitted to the agency’s Adverse Event Reporting Systems (FAERS). There may be additional cases that the FDA is not aware of, the agency said.

There were 167 reports of impulse-control problems in the United States affecting both children and adults. Pathological gambling, which was listed in 164 reports, was the most common behavior. However, other uncontrollable urges were mentioned as well, including: compulsive eating, spending or shopping, and sexual behavior.

The FDA stated that “In the majority of cases, patients with no prior history of the compulsive behaviors experienced uncontrollable urges only after starting aripiprazole treatment. Within days to weeks of reducing the dose or discontinuing aripiprazole, these uncontrollable urges stopped.”

Bristol-Myers Squibb and Otsuka Pharmaceutical are facing allegations that they failed to warn about the risk of pathological gambling and other compulsive behaviors associated with Abilify. Users say the gambling addiction and impulse-control problems led to financial ruin, impaired social relationships and caused emotional distress.

In a letter issued last April, the FDA cited Abilify promotional material that was “false or misleading because it makes misleading claims and presentations about the drug.” The FDA said the materials were “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.”