A woman claims she wasn’t warned of the link between Abilify and pathological gambling, and that she has suffered severe emotional and financial distress.

Plaintiff LaRitha V. says she took prescription Abilify from December 2013 through November 2016.  She alleges a link between Abilify and pathological gambling caused her to develop a compulsive gambling habit.

Abilify is used to treat depression, bipolar I disorder and schizophrenia.

According to plaintiffs in the Abilify and pathological gambling multidistrict litigation, the drug’s makers knew that patients were at an increased risk of uncontrollable and compulsive behaviors.

Abilify’s labeling in Europe and Canada warns of the risks of “pathological gambling.” But plaintiffs claim the drug companies allegedly kept this information from the U.S. market, because prior to January 2016, the label on the U.S. packaging never mentioned the possibility of developing compulsive behaviors of any kind.

In May 2016, the FDA ordered the drug’s warning label include uncontrollable, compulsive urges like gambling, eating, shopping, and having sex. Now, the prescription label warns that the Abilify patient might not recognize the abnormal behavior this drug may cause. It also warns that the patient taking Abilify could cause harm to himself or to others without realizing the consequences of his/her actions.

The label specifically reads, “Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.”

Plaintiffs Say Abilify and Pathological Gambling Link Known for Years

Abilify was introduced to the U.S. market in the fall of 2002. In the fall of 2012, the European Medicines Agency demanded that the drug makers warn patients and the European health care community that Abilify and pathological gambling were linked.

The European Medicines Agency required the following label:

“Pathological Gambling. Post-marketing reports of pathological gambling have been reported among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling. Patients with a prior history of pathological gambling may be at increased risk and should be monitored carefully.”

In the fall of 2015, Canada’s drug regulators found an increased risk of pathological gambling and hypersexuality in Abilify users, thereby prompting a warning label update. However, the U.S. label failed to address these compulsions until January 2016.

According to the Abilify and pathological gambling lawsuit, the drug makers “have made significantly more revenue from Abilify sales in the United States compared to Europe” because of the label’s omissions.

In 2013, Abilify was Bristol-Myers’ biggest seller with sales of $2.3 billion. U.S. revenues from Abilify over just a three-month period in 2014 totaled $417 million, compared to worldwide revenues of $555 million during that same time span.

Even though the U.S. market approved Abilify as an adjunctive treatment for patients with depression in 2007, the European market declined to grant similar approval. The European Medicines Agency expressed concern that Abilify was not effective as an add-on treatment for depression.

The Abilify and Pathological Gambling Lawsuit is Case No. 3:17-cv-00847-MCR-GRJ and is part of the Abilify MDL, In re: Abilify (aripiprazole) Products Liability Litigation, MDL No. 2734, in the U.S. District Court for the Northern District of Florida, Pensacola Division.