HACKENSACK, N.J. (CN) - The anti-depressant drug Abilify gave a man a compulsive gambling habit that cost him more than $75,000, he says in a lawsuit against Bristol-Myers Squibb and Otsuka Pharmaceuticals.
Jonathan Yun says the drugmakers did not properly warn him about a known side effect of the blockbuster drug, whose sales revenue exceeds $1 billion a year.
In Yun's Jan. 12 complaint in Bergen County Court, he says that after he began taking Abilify drug in December 2010, he "began compulsively gambling shortly thereafter, and stopped compulsively gambling soon after [he] had ceased taking Abilify" in August 2013.
Abilify, which is prescribed for depression, bipolar I disorder, and schizophrenia, hit the U.S. market in 2002. U.S. revenue was $417 million in the three months ending June 30, 2014, and worldwide revenue in that time was $555 million, according to the complaint.
Yun says the warning labels on Abilify vary significantly by country. In 2012, "the European Medicines Agency required that defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling," he says in the lawsuit.
And in November 2015, "Canadian regulators concluded that there is 'a link between the use of aripiprazole [Abilify] and a possible risk of pathological gambling or hypersexuality' and found an increased risk of pathological (uncontrollable) gambling and hypersexuality with the use of Abilify," according to the complaint.
But despite the warnings on two continents, Yun says, "the labeling for Abilify in the United States contains no mention that pathological gambling has been reported in patients prescribed Abilify."
Abilify affects patients' dopamine levels. Other modern antidepressants affect other neurotransmitters, such as serotonin (Prozac).
"Dopamine is a neurotransmitter that helps control the brain's reward and pleasure centers," Yun says in the complaint. "Dopamine's role in compulsive behavior and pathological gambling is well-known. ... Scientific literature has identified dopamine as a potential cause of pathological gambling for years."
Yun claims that 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."
Also: "An analysis of the FDA Adverse Event Reporting System shows an escalating number of reports" of compulsive gambling: "twenty-nine reports of gambling behavior were made to the FDA in 2014" about Abilify, according to the complaint.
The warning label for Abilify in the United States does list serious side effects that have been reported, but Yun says, "it does not list gambling, pathological or otherwise, nor does it mention compulsive behaviors."
Bristol-Myers and Otsuka "had, or should have had, knowledge that Abilify can cause compulsive behaviors like gambling" and that "despite their significant collective resources, and signals that Abilify is associated with compulsive behaviors such as gambling, [they] have failed to fully and adequately test or research Abilify and its association with compulsive behaviors."
Bizarre as the claim may sound, it is far from unprecedented.
More than 400 lawsuits with similar claims have been filed about Mirapex, which is prescribed for Parkinson's disease. A compulsive gambler who lost $260,000 won an $8.2 million judgment against Pfizer and Boehringer Ingelheim in 2008.
The Archives of Neurology in 2005 reported on a Mayo Clinic study that found Parkinson's patients developed compulsive behaviors while taking Mirapex, including a 68-year-old man who gambled away $200,000 in six months.
In 2003, the medical journal Neurology reported a study that found that eight of 529 Parkinson's patients who took Mirapex developed gambling addictions during the yearlong study. The drugmakers changed their warning labels to include the dangers of addictive behaviors. Most reports indicate that the compulsions subside when the patients stopped taking the drug.
Bristol-Myers spokeswoman Laura Hortas declined to comment on the lawsuit.
Yun seeks disgorgement, unjust profits and actual and punitive damages for fraud, breach of contract and negligence.
He is represented by Rayna Kessler with Robins Kaplan in New York City.
Two similar lawsuits were filed Jan. 15 in Tampa Federal Court.
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