A complaint filed last week in the U.S. District Court for the Northern District of Florida alleges that drug makers Bristol-Myers Squibb and Otsuka Pharmaceutical Co. knew or should have known and failed to warn consumers and medical professionals that the antipsychotic medication Abilify can cause compulsive behavior, including addictions to gambling, sex, and shopping.
Although the European Medicines Agency has required Abilify warnings about the risk of compulsive gambling since 2012 and regulatory officials in Canada required similar warnings in late 2015, such warnings were not provided to consumers in the U.S. until very recently.
On May 3, 2016, the U.S. Food and Drug Administration (FDA) issued a warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of Abilify, and the urges are reported to have stopped when the medication was discontinued or the dose reduced. According to the FDA, the updated Abilify warning label will include warnings about all these compulsive behaviors.
What is Abilify?
One of the top selling drugs in the U.S., the FDA approved Abilify in 2002 to treat schizophrenia, bi-polar disorder, and other major depressive disorders. It is also frequently prescribed off-label to treat irritability, aggression, mood swings, and other psychological conditions.
Since approval, 167 case reports describing an association between Abilify use and impulse-control problems have appeared on the FDA’s Adverse Event Reporting System (FAERS) database. Of these reports, most involved pathological gambling that began only after starting Abilify and resolved within days to weeks after reducing the dose or discontinuing the medication completely. None of the 167 patients studied had a history of pathological gambling, compulsive sexual behavior, binge eating, or compulsive shopping prior to starting Abilify.
A growing number of plaintiffs in the U.S. are currently pursuing Abilify gambling lawsuits against Bristol-Myers Squibb and Otsuka for failing to adequately warn consumers about the risk of compulsive behaviors that can potentially lead to financial ruin, damaged relationships, and a negative impact upon an individual’s overall quality of life.
For these reasons and many others, the Abilify lawyers at Childers, Schlueter & Smith continue to review and investigate Abilify cases in patients that experienced pathological gambling addictions and have sustained verifiable gaming losses in excess of $50,000. If you have questions about a potential claim or just need more information, please contact our office right now to see how we can help. Toll free or via email at Intake@cssfirm.com