Abilify Gambling Problems Seen In FDA Adverse Event Reports For Years, Lawsuit Claims

As a growing number of people nationwide continue to file lawsuits over Abilify gambling problems, one of the latest cases alleges that the drug makers knew or should have known about the risk for years, pointing to adverse event reports submitted to the FDA involving sudden impulse control problems experienced among users of the popular atypical antipsychotic medication.

The complaint (PDF) was filed by Tae Cho, who indicates that he began taking Abilify in 2007, and began to compulsively gamble. Cho’s gambling problems ceased after Abilify treatment was stopped in December 2014, indicating that he could have avoided substantial losses and financial problems if warnings had been provided by the drug maker.

Abilify (ariprazole) is one of the top-selling brand name medications on the market in the United States, generating sales in excess of $6 billion per year, and widely used by millions of Americans for treatment of schizophrenia, bipolar disorder and other major depressive disorders. It is also widely used off-label to treat irritability, aggression, mood swings and other behavior issues. Patented by Otsuka scientists, it is distributed in the U.S. by Otsuka and Bristol-Myers Squibb.

Cho indicates that he did not discover the link between Abilify and gambling problems until 2014, after he had already suffered losses in excess of $75,000, as well as loss of financial stability and other damages.

Although compulsive gambling warnings were added to Abilify in several other countries a number of years ago, the drug has been sold in the United States without any mention that it may cause users to engage in unusual compulsive behaviors, until recently.

The FDA required the drug makers to add Abilify gambling warnings for the first itme in May 2016, confirming that the drug may cause an uncontrollable urge to gamble, shop, have sex or engage in other compulsive behaviors. Due to the lack of prior warnings in the U.S., most doctors were unaware of the importance of monitoring patients for the emergence of addictive behaviors, and users were told to contact their healthcare provider if they experienced the side effects.

According to allegations raised in the lawsuit filed by Cho, the drug makers knew or should have known about the Abilify gambling risks years earlier, when an analysis of FDA adverse events strongly indicated there was a problem.

“From 2005 to 2013, an FDA report showed that Abilify accounted for at least fifty-four reports of compulsive or impulsive behavior problems, including thirty reports of compulsive gambling, twelve reports of impulsive behavior, nine reports of hypersexuality, and three reports of compulsive shopping,” the lawsuit states. “A disproportionality study of the FDA Adverse Event Reporting System showed a proportional reporting ratio for compulsivity of 8.6 for Abilify. A ratio of more than three indicates a signal of an adverse event.”

Addictive gambling on Abilify can have a severe impact on users, causing severe financial losses and behavior that can destroy families, reputations and cause irreparable damage to an individual’s quality of life. Cho and other plaintiffs nationwide allege that if warnings had been provided about the risk of impulsive behaviors, they may have avoided devastating consequences by recognizing the potential side effects associated with the medication and stopping use of the drug.