The active ingredient in Abilify is a chemical called aripiprazole. Used primarily to treat schizophrenia and manic or mixed episodes in people with bipolar 1 disorder, Abilify has grown, from its initial approval in 2002, to become America’s best-selling drug, in large part because it’s extremely expensive. Despite the expense, nearly 2 million patients receive a prescription for aripiprazole every year. And, while it’s not approved for these uses, the drug has also become a popular treatment for generalized anxiety disorders, eating disorders and obsessive-compulsive disorder.
How Does Abilify Work?
Abilify is often referred to as an “atypical” antipsychotic, because it works differently from older drugs that were used for psychological disorders. While the medication’s mechanism of action is still poorly-understood, researchers generally believe that aripiprazole acts as a “partial agonist” for the brain’s dopamine and serotonin receptors.
Dopamine and serotonin are two neurotransmitters, chemicals that communicate information between nerve cells, or “neurons.” And most psychiatrists, according to Thought Broadcast, think that these two neurotransmitters are to blame in a wide range of pathological behavior disorders. Abilify gets in the way. Aripiprazole, the chemical in Abilify, binds to the same neural receptors that are usually occupied by bits of dopamine or serotonin. But as a “partial agonist,” the chemical only binds to these receptors partially. It activates the receptors a bit, but not fully.
Dopamine & The Reward Pathway
So why is that a problem? As plaintiffs note in their lawsuits, the neurotransmitter dopamine appears to be at the center of “the brain’s reward and pleasure centers.” To speak loosely, when we feel “good” after doing something, it’s because a little spurt of dopamine just went off in our brains. And that “good” feeling makes us want to do more of whatever made us feel good.
The Role Of Neurotransmitters In Compulsive Behavior
It’s also likely that dopamine is, at least in part, at the heart of many addiction disorders. Addictive substances or compulsive behaviors result in a neurological “reward,” a spurt of dopamine, that makes us want to do more and more and more.
This mechanism has been observed in problem gamblers. As researchers in Frontiers in Behavioral Neuroscience wrote in 2013, “dopamine [….] is indeed released to a larger extent in pathological gamblers than in healthy controls.” It’s not money that drives gambling addiction, the authors continue, but a problem in the brain. And Abilify, patients claim, seems to cause this problem.
Patients: Abilify Manufacturers Had Knowledge Of Risks
In 2004, three psychiatrists at Dartmouth Medical School noted as much, finding a link between drugs that mediate the action of dopamine neurons, including aripiprazole, and an increase in behaviors driven by the brain’s reward pathways.
These results weren’t missed by Otsuka Pharmaceutical, the company that developed and manufactures Abilify. In fact, the report from Dartmouth was cited by the manufacturer in a 2011 safety document submitted to the European Medicines Agency. The same update also informed European health regulators of 7 “serious reports of pathological gambling,” along with 16 other cases logged with Bristol-Myers Squibb, who commercialized Abilify in the United States.
European Health Agency Warns Patients In 2012
Apparently, the report was enough to worry the European regulatory authorities. In late-2012, the European Medicines Agency ordered Bristol-Myers Squibb and Otsuka to warn patients and medical providers about Abilify’s link to compulsive gambling. That year, a new paragraph appeared in the Special Warnings and Precautions for Use section on the drug’s European label:
“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.”
“Pathological gambling” was also added to a section titled “Undesirable effects.”
Canada Adds Warning In 2015
Three years later, Canadian health regulators came to much the same conclusion. In November of that year, Health Canada released a public warning titled “Safety information for antipsychotic drug Abilify and risk of certain impulse-control behaviors.” As the agency wrote, Abilify’s Canadian label had been updated to reflect an increased risk of pathological gambling and hypersexuality.
Canada’s review of the medical literature had “identified 18 international cases of pathological gambling and six international cases of hypersexuality,” the health agency wrote. “In most cases, the behaviors ceased or improved when treatment was stopped or when the dose was reduced, suggesting a direct link between the drug and the side effect.”
FDA Forces Label Change For Impulse-Control Disorders
But it would take another year for patients and healthcare professionals in the United States to receive a similar warning. And the first hint of change was strangely quiet, plaintiffs write. In January 2016, they say, “pathological gambling” was added only to the Postmarketing Experience section of the [US] label.” There was no fanfare, no public announcement. Just two extra words added to a section buried on the 42nd page of Abilify’s prescribing pamphlet.
That wasn’t enough for the US Food & Drug Administration. By May, the FDA decided to take matters into its own hands, issued a public warning that linked Abilify, not only to compulsive gambling, but to a broad range of impulse-control disorders.
“Compulsive or uncontrollable urges to gamble, binge eat, shop and have sex,” FDA researchers wrote, “have been reported with the use of the antipsychotic drug aripiprazole.” Abilify’s US label was subsequently updated with a full workup on the drug’s link to compulsive behavior, including problem gambling.
Did Otsuka, BMS Fail To Warn US Patients?
Otsuka and Bristol-Myers Squibb cheated the American people, plaintiffs claim. Both companies had a duty, both ethically and legally, to properly warn patients and medical care providers of Abilify’s risks, lawsuits argue. And both companies miserably failed to do so, patients continue.
As we’ve seen, ample evidence in the medical literature suggests that Abilify’s active ingredient, aripiprazole, is tied to a rise in the risk for compulsive behavior. Two international health agencies considered this evidence so compelling that they slapped Abilify with new label warnings. Yet similar measures weren’t taken in the United States until the FDA was forced to do so, plaintiffs say.
“Defendants wrongfully and unjustly profited at the expense of patient safety and full disclosure to the medical community,” court filings allege, “by failing to include language about gambling in the United States labeling and by failing to otherwise warn the public and the medical community about Abilify’s association with gambling – despite opportunities and a duty to do so.”
Gambling, Compulsive Behaviors Threaten Families
The manufacturers also cheated individual patients, lawsuits claim. In court documents, hundreds of plaintiffs describe heart-breaking stories of addiction.
A woman pawns off her husband’s work tools to feed her gambling compulsion. Another patient becomes increasingly consumed by the world of sexual hookups, soliciting men online behind the back of her husband. Men driven to borrow inordinate sums of money, imperiling their family’s financial security, to fuel a newly-emergent addiction to shopping.
Nearly 600 patients say Abilify led them into financial ruin, but the harm went far beyond a bank account or unemployment check. Over and over, patients save their most-poignant words to describe the loss in security and control they blame on Abilify. The urges were “mentally crippling,” one patient writes.
Abilify Patients Fight For Compensation In Florida Court
And it’s not enough to provide future patients with an adequate warning, plaintiffs say. Otsuka Pharmaceutical and Bristol-Myers Squibb owe full and fair compensation, lawsuits contend, to make up for the harm done to unsuspecting patients.
Today, over 560 Abilify lawsuits are consolidated in the US District Court for Northern Florida. Due to their similar allegations, the cases have centralized to make legal proceedings more efficient. As a result, claims filed in a federal court, no matter the jurisdiction, are likely to be transferred to the Northern District of Florida. The Honorable M. Casey Rodgers is presiding over this Multi-District Litigation. The lawsuits are now proceeding through discovery, the phase of a lawsuit in which evidence is exchanged and examined, as a group.