In January 2016, a lawsuit was filed by a man who began gambling after he started taking Abilify in 2004. He lost over $50,000 by the time he stopped Abilify a decade later — Case No. 1:16-cv-00271.
In September 2016, a man who gambled away $375,000 while taking Abilify from 2007 to 2015 filed a lawsuit against drug-makers for failing to warn about the risk — Case No. 1:16-cv-00384
The cases are part of a centralized federal Multi-District Litigation (MDL No. 2734) involving nearly 200 lawsuits the Northern District of Florida. Unlike a class action, Abilify lawsuits are independent and the MDL includes plaintiffs nationwide.
Lawyers accuse Bristol-Myers Squibb and Otsuka Pharmaceuticals of failing to warn about gambling addiction and other known side effects to protect sales of Abilify in the U.S., prioritizing profits over safety.
The FDA received 164 reports of pathological gambling from Abilify from November 2002 through January 2016, the same month drug-makers tried to bury the side effect in a long list of post-marketing event reports.
It was not until the FDA ordered stronger labels in May 2016 that American patients and doctors were finally warned about uncontrollable urges to gamble, eat, shop, or have sex — years after similar warnings were added internationally.
Europe required BMS and Otsuka to add a warning label about “pathological gambling” from Abilify in November 2012, as well as recommending caution in patients with a history of gambling addiction.
Canada required warnings about impulse control problems, including compulsive gambling and hyper-sexuality, on the Abilify label in November 2015.
The U.S. label on Abilify also states that patients may not be able to recognize their addictive behaviors are unusual, so doctors must ask. Furthermore, patients may be too embarrassed to tell anyone, or fail to disclose a history of addiction.
The problem is that Abilify works by changing brain chemistry. It belongs to a class of anti-psychotic medications known as dopamine partial agonists, which treat schizophrenia and bipolar disorder by balancing levels of neurotransmitters in the brain.
The neurotransmitters dopamine and serotonin play a key role in the brain’s reward system. They are released during fun activities to reinforce behaviors and create cravings to do the behavior again.
Abilify amplifies these effects. Patients may feel intense pleasure and equally-intense cravings to do enjoyable activities. Over time, this can lead to uncontrollable addiction — with devastating consequences. BMS and Otsuka are accused of downplaying the risk.
In 2007, BMS paid a $515 million settlement to resolve state and federal investigations into off-label marketing of Abilify for children and the treatment of dementia-related psychosis, a use that now carries a Boxed Warning about the risk of death.
The settlement did not end off-label marketing. In 2015, the FDA sent BMS a warning letter for making “false or misleading” claims about Abilify in advertisements. In July 2016, BMS paid another $30 million settlement in California for allegedly rewarding doctors who prescribed Abilify with lavish dinners, resort hotel trips, golf, concert tickets, and more.