Abilify lawsuits filed on behalf of individuals who allegedly developed impulsive gambling habits due to treatment with the atypical antipsychotic medication continue to mount in courts around the U.S.
Most recently, a group of five Nevadans filed suit in Washoe County District Court accusing Otsuka Pharmaceuticals and Bristol-Myers Squibb of neglecting to adequately warn the public of Abilify’s potential to cause compulsive disorders, “despite opportunities and a duty to do so.”
According to the Las Vegas Review-Journal, the March 7th complaint notes that the U.S. Food & Drug Administration (FDA) received at least 30 reports of compulsive gambling, as well as 24 reports of other impulsive behaviors, in connection with Abilify from 2005 through 2015.
The complaints further point out that in 2011, the defendants submitted a report to the European Medicines Agency – the FDA’s equivalent in Europe – stating that the possible link between Abilify and compulsive gambling “could not be excluded.” While the drug’s European label was updated as a result of that report, the companies did not advertise this potential side effect in the U.S. medication guide for Abilify.
In May 2016, the FDA announced that a review of its adverse event database had uncovered more than 180 reports of impulse control disorders – mostly involving compulsive gambling, though some reports involved compulsive sexual behavior, shopping and eating – among patients treated with aripiprazole. In the majority of cases, the affected patients had no prior history of impulse control disorders, and, in most cases, the behaviors ceased once the patients stopped using the drug or had their dosage decreased.
“Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions,” the agency said in a statement. “These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.”
All federally-filed Abilify gambling lawsuits have been centralized before a single judge in the U.S. District Court, Northern District of Florida, where more than 1,000 cases are now undergoing coordinated pretrial proceedings.
The litigation will begin a series of three bellwether trials in June, per the following schedule:
Verdicts in these trials may provide some insight into how other juries will rule in similar Abilify lawsuits.