A Minnesota woman, Denise Miley, is suing Bristol-Myers Squibb and Otsuka Pharmaceutical, alleging that their depression and anxiety drug Abilify (aripiprazole) caused a gambling impulse. She filed the suit in January 2016, claiming that the companies knew or should have known that the drug could cause compulsive gambling.
Her suit isn’t the only one. There are hundreds more claiming that Abilify resulted in a number of compulsive behaviors, including gambling, eating and sex. The U.S. Food and Drug Administration (FDA) expressed its own concerns in a 2016 safety warning, noting uncontrollable urges to gamble, binge eat, shop, and have sex.
“We have people who have lost their retirement accounts, spent their children’s college funds, blown through a lifetime of savings,” said Gary Wilson, a lawyer with Robins Kaplam, the firm representing Miley and some of the other plaintiffs.
STAT notes, “Scientists haven’t figured out how, exactly, a drug might trigger compulsive behavior. Psychiatrists say that even if Abilify does have a role, it’s probably just part of the explanation, since millions of people take the drug without experiencing such problems.”
Japanese firm Otsuka developed the drug and Bristol-Myers Squibb markets it jointly in the U.S. with Otsuka. Both companies have denied the allegations.
Levin Papantonio, a law firm in Pensacola, Florida, notes that as of July 2018, more than 1,600 lawsuits have been filed against the companies over Abilify in federal court. Papantonio writes, “Court records state the drug makers failed to properly test Abilify; exaggerated the benefits of the drug; and encouraged physicians to use the medication for purposes not approved by the FDA. Abilify is not approved to treat anxiety disorders, dementia, eating disorders, insomnia, obsessive-compulsive disorder, or post-traumatic stress disorder. Yet, the makers of Abilify convinced doctors to try it for these conditions.”
The drug was originally approved in 2002 by the FDA to treat schizophrenia. Since then it has been approved for bipolar disorder, irritability linked with autism, Tourette’s syndrome, and major depressive disorder. In 2007, Bristol-Myers Squibb paid more than $500 million to settle federal charges that it “illegally marketed the drug to pediatric physicians and nursing homes,” writes STAT. “And in 2016, the company reached a $19.5 million settlement with 42 states and Washington, D.C., which accused the drug maker of illegally promoting Abilify to people with Alzheimer’s disease and other forms of dementia.”
The drug is one of the most-prescribed drugs on the market, despite facing generic competition since 2015. Since it was approved, the brand-name version has brought in more than $51 billion—yes, billion with a “b”—worldwide. And the drug has another landmark—the FDA approved Abilify MyCite in 2017, “a version of the drug embedded with a sensor that can alert a patient’s physician or caregiver when it’s been ingested. It was the first approval of a so-called smart pill,” STAT writes.
The European Medicines Agency (EMA) issued a warning about the drug in 2012, linking it to compulsive behavior, and in 2015, Canada’s regulatory agency did the same thing. However, “pathological gambling” wasn’t added to the warning labels until January 2016. The FDA didn’t issue a warning until May 2016.
Meanwhile, much of the court battles revolve around whether the drug is the cause of the impulse control issues, and if it is, how it does so. Abilify partially blocks dopamine, a neurotransmitter that transports signals between neurons in the brain. It has quite a number of roles in the brain, including regulating reward processing, pleasure and motivation.
But with a drug used by millions, only a small proportion are showing these problems. “If it were as simple as it causing [the behavior], then the streets would be filled with impulsive people,” Jon Grant, a psychiatrist at the University of Chicago, told STAT.
But that is the very nature of drugs when it comes to side effects. There are significant genetic components to how individuals process drugs, which is why some people have few, if any, side effects and others may have severe side effects. And when it comes to the central nervous system, those effects are often more complicated and difficult to understand.
Still, anecdotally at least, these people started their compulsive behavior when they started taking the drug, and the behavior stops when they stop taking the drug. And it appears that other drugs that affect the dopamine system, such as drugs for Parkinson’s Disease, have also been linked to compulsive behavior.
A Product Manager with expertise in pharma marketing and sales operations