A new lawsuit by a New Jersey man says the Abilify he took gave him a costly gambling addiction.

Plaintiff Jonathan Y. says he started uncontrollably gambling soon after he began taking Abilify in December 2010. His gambling addiction continued as long as he took the drug and stopped only after he discontinued treatment in August 2013.

Abilify, known generically as aripiprazole, is a psychiatric medication that’s been on the market since 2002. It’s now approved by the FDA as a treatment for schizophrenia and manic or mixed episodes associated with bipolar disorder.

Abilify may be used in combination with antidepressants to treat depressive symptoms that don’t respond to antidepressants alone. In younger patients, Abilify may be used to treat autism and Tourette’s disorder.

Abilify has produced enormous revenue for makers Bristol-Myers Squibb and the Otsuka Pharmaceutical Company. Sales within the U.S. have reached over $6.4 billion.

The drug operates on the neurotransmitters dopamine and serotonin, which are part of the brain’s natural reward system. This same mechanism of action that can treat pathological psychiatric symptoms may also be linked to possible Abilify side effects like gambling addiction. Researchers theorize Abilify may lead to over-stimulation of the reward system, encouraging compulsive behavior.

Abilify and Gambling Addiction

Jonathan says that although the drug’s U.S. labeling lists certain Abilify side effects, it doesn’t warn patients and doctors about the risk of gambling addiction or other compulsive behaviors.

For comparison, he points out that warning labels in Europe have alerted Abilify patients to the risk of gambling addiction since 2012. In Canada, regulators concluded in 2015 that Abilify was linked to a possible risk of compulsive gambling or other compulsive behaviors like hypersexuality.

Within the U.S., Jonathan says the FDA’s Adverse Event Reporting System has been logging an increasing number of reports of compulsive gambling associated with Abilify treatment. Twenty-nine such reports were submitted in 2014, he says.

Given these reports to the FDA and regulatory action in other countries, Jonathan believes that Bristol-Myers and Otsuka either knew or should have known about the connection between Abilify and compulsive behaviors. He says the companies failed to fully evaluate that connection and warn the public accordingly.

New FDA Warning

In May 2015, the FDA issued a Drug Safety Communication warning about the various and destructive compulsive behaviors reported in conjunction with Abilify and other medications that used aripiprazole. The agency says it will require the labeling for Abilify to carry a warning about the risk of these Abilify side effects.

The agency noted that the list of compulsive behaviors associated with these drugs goes beyond just gambling addiction. Some patients also reported compulsive shopping, eating, and sexual activity. The agency says that although these cases were relatively rare, they can result in harm to the patient and others if they are not recognized and addressed effectively.

The FDA encourages patients and caregivers to be on the watch for excessive and uncontrollable urges while taking Abilify or other aripiprazole drugs. The agency advises patients to consult their care providers as soon as possible if they experience such symptoms. They add that patients should not discontinue medication without checking with their care provider first.