Lawsuit Alleged Abilify Pathological Gambling. Abilify is an antipsychotic medication used to treat psychiatric conditions such as depression, bipolar I disorder, schizophrenia, and autism spectrum disorders.
The U.S. Food and Drug Administration (FDA) approved Abilify in 2002. Now, drug manufacturers Otsuka Pharmaceuticals and Bristol-Myers Squibb are faced with a growing number of lawsuits alleging that Abilify led to pathological gambling. Plaintiffs in the litigation allege that the drug makers failed to warn patients or their doctors about this risk.
Litigation is mounting against Bristol-Myers Squibb and Otsuka Pharmaceuticals. Lawsuits are being filed on behalf of individuals who allege that they suffered a gambling addiction, a problem which they never experienced in the past, after starting Abilify.
The suits allege that drug makers were aware of the risk of pathological gambling with Abilify but failed to update the warning label on this drug until very recently.
Federal lawsuits have been consolidated into a multidistrict litigation in Florida. When there are numerous lawsuits with similar allegations, sometimes the U.S. Judicial Panel on Multidistrict Litigation will establish an MDL to make the complex litigation move along faster. Consolidating these cases to one court eliminates duplicate discovery and overall conserves court resources.
A lawsuit was recently filed into the MDL
A lawsuit was recently filed into the MDL. Like other cases in the litigation, the lawsuit alleged that taking Abilify led to pathological gambling. The plaintiff is a woman from Colorado who started taking Abilify in 2007. She alleges that her gambling addiction, which persisted until December 2014, caused her to lose $75,000.
The plaintiff alleges that she would not have taken Abilify if she knew there was a risk of pathological gambling. Allegedly, Otsuka and Bristol-Myers Squibb knew about the risk of pathological gambling but failed to warn patients or the medical community.
In the United States, pathological gambling was added to the warning label only this year, in January. The label was revised again in May 2016 to warn about the risk of other impulse-control behaviors associated with Abilify, including the urge to binge eat, shop and have sex.
The agency noted that for most patients, there was no history of impulse-control problems before taking Abilify. These compulsive behavioral issues only appeared after starting Abilify, and stopped or reduced once stopping the medication, the agency said.
The FDA noted that although “pathological gambling” was listed under “Postmarketing Experience”
In its May notification, the FDA noted that although “pathological gambling” was listed under “Postmarketing Experience”, this did not encompass the various other impulse-control problems reported by Abilify users. The label update affected Abilify, Abilify Maintena, Aristada, and generics.
Since Abilify was approved in 2002, a total of 184 reports of impulse-control problems were submitted to the FDA’s Adverse Event Reporting System. The FDA notes that more cases may exist, since the search only includes reports in the database. Of the impulse-control problems reported, 167 cases were in the United States.
The adverse event reports with Abilify included both adults and children. The most common problem was pathological gambling, but other compulsive behaviors such as binge eating, shopping and sexual behaviors were also reported.