Abilify Pathological Gambling Problems Withheld from Medical Community, Lawsuit Alleges

According to allegations raised in a recently filed product liability lawsuit, Bristol-Myers Squibb and Otsuka Pharmaceutical Co. have withheld information from consumers and the medical community about the risk of pathological gambling problems on Abilify, which is one of the top-selling brand name medications on the market.

The complaint (PDF) was filed by Thomas Leland in the U.S. District Court for the Western District of Missouri on January 20, indicating that after he began using the atypical antipsychotic medication he suffered substantial gambling losses, lost his employment, severely damage to his financial stability and suffered other mental and physical losses.

Leland indicates that he was prescribed Abilify in March 2013, and began compulsively gambling shortly thereafter. After he stopped taking the medication in about August 2015, Leland states that his pathological gambling stopped a short time later.

The lawsuit alleges that side effects of Abilify caused him to engage in the pathological gambling behavior, adversely impacting his brain.

Abilify (ariprazole) is typically prescribed for treatment of schizophrenia, bipolar disorder and as an adjunct for depression and autism spectrum disorders, generating annual sales of more than $6 billion per year, making it the top selling brand name drug on the market in 2013.

In about November 2012, European drug regulators required Abilify pathological gambling warnings, adding information to the label about reports of users engaging in uncontrollable gambling activities and recommending that patients should be monitored carefully. However, similar warnings were not provided to doctors in the United States.

Similar warnings about the link between Abilify and gambling were provided to the Canadian medical community in November 2015, after drug regulators identified cases where users began compulsive gambling or hypersexuality behavior.

“Despite these warnings and advisories in Europe and Canada – for the same drug sold to patients in the United States – the labeling for Abilify in the United States contains no mention that pathological gambling has been reported in patients prescribed Abilify,” according to the complaint filed by Leland.

In an October 2014 study published in the medical journal JAMA Internal Medicine, researchers found evidencethat a class of drugs known as dopamine receptor agonists, often used to treat Parkinson’s disease, were linked to gambling and impulse control problems. However, the researchers also saw the same behavioral problems associated with the use of Abilify, which is a partial dopamine agonist.

Leland notes that Bristol-Myers Squibb and Otsuka have been aware for years of case reports linking Abilify to pathological gambling behaviors, including several case reports that demonstrate strong evidence of a causal connection through “challenge, de-challenge and re-challenge.” This term is used to describe a situation where an adverse event begins when use of a drug starts (challenge), ceases when the drug is no longer used (de-challenge), but returns when the medication is taken again (re-challenge).

“Despite evidence that Abilify causes compulsive behaviors like pathological gambling and calls from the medical community to conduct further research and warn patients about this possible effect of Abilify, Defendants have either failed to investigate or conduct any studies on the compulsive behavior side effects of Abilify or failed to make public the results of any studies or investigations that they might have done,” the lawsuit states.

The complaint indicates that an analysis of the FDA Adverse Event Report System has demonstrated an escalating number of reports involving Abilify compulsivity, inclyding at least 29 reports of pathological gambling with Abilify in 2014.

Addictive gambling on Abilify can have a severe impact on users, causing substantial financial losses and behavior that can destroy families, reputations and cause irreparable damage to an individuals quality of life.

Leland’s case comes a growing number of similar Abilify gambling lawsuits are being pursued by other users, alleging that plaintiffs may have avoided devastating consequences on their financial situation and quality of life if users and the medical community had been warned to be on the look out for signs of compulsive gambling or other pathological behaviors while using the drug.