Hundreds of Abilify patients say the popular antipsychotic drug leads to devastating impulse-control problems, including compulsive gambling, shopping, eating and sex.
- Nearly 600 lawsuits
- MDL in Florida federal court
- Time may be limited
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Nearly 600 current and former patients say Abilify, an antipsychotic medication, causes harmful compulsive behaviors, including compulsive gambling. Hundreds of civil lawsuits against Bristol-Myers Squibb and Otsuka Pharmaceutical, the drug’s manufacturers, are now consolidated in a Florida federal court. And, at the beginning of 2018, the Abilify litigation has shown no sign of slowing down, with dozens of new claims for compensation filed already.
FDA Warns Of Link To Compulsive Behavior
Abilify is an atypical antipsychotic drug prescribed to treat various mental disorders, including schizophrenia, bipolar disorder and, as an adjunct to traditional treatments, major depressive disorder. Approved by the US Food & Drug Administration in 2002, Abilify is now the nation’s best-selling drug, according to Quartz, with annual sales in excess of $7.5 billion.
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In May 2016, a new warning appeared on the drug’s label. As experts at the FDA wrote, Abilify had been linked to rare, but potentially life-altering, impulse-control problems. Public health researchers had received reports of compulsive, or uncontrollable, behaviors in Abilify patients, the vast majority of whom had never experienced these problems before.
And, while a labeling update (initiated by the drug’s manufacturers) in January 2016 had contained a brief mention of “pathological gambling,” the previous language didn’t “entirely reflect the nature of the impulse-control risk that [FDA researchers] identified,” the agency wrote. Alongside compulsive gambling, newer results had found an association between Abilify’s active ingredient, a chemical called aripiprazole, and compulsive behaviors in general.
Gambling, Eating, Shopping & Sex
Abilify patients had also been struck by uncontrollable urges to eat, shop and have sex. Within 13 years, the FDA’s adverse event report database had logged at least 184 reports linking Abilify to impulse-control disorders. 167 of these cases pertained to US patients. And while pathological gambling accounted for the largest portion of reports, Abilify had also been mentioned in reports of:
- compulsive eating
- compulsive spending or shopping
- compulsive sexual behavior
Overwhelmingly, this compulsive behavior was being reported in patients with no prior history of impulse-control problems.
“The Drug Triggers A Pathological Urge”
In the majority of cases, FDA reviewers said, the problems only began when the patients started taking Abilify. They stopped soon after the drug was discontinued. In medical circles, that’s known as a dechallenge reaction. When patients stop taking Abilify (their body systems are no longer “challenged” by the medication), the compulsive urges appear to subside. This positive dechallenge result provides us with evidence that Abilify is causing the adverse effect, rather than some other as-yet unspecified factor.
So while the issue of compulsive behavior seems to be rare (about 1.6 million people receive a prescription for apiprapazole every year), it’s probably connected to the antipsychotic drug. “The drug triggers a pathological urge to gamble constantly,” according to Thomas Moore, a senior researcher at the Institute for Safe Medication Practices. “It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.” Moore spoke with the Daily Beast in November 2016.
High Risk Of Impulse-Control Disorders
Compulsive behavior is a very rare side effect of pharmaceuticals, regardless of what drug we’re talking about. So 184 reports may sound small, but it’s actually a high number where medications are concerned. In fact, studies of FDA data show that Abilify is between 8.6 and 64-times more likely to be linked to compulsive gambling than other drugs.
US Label Update Comes In 2016
By August 2016, a new warning on Abilify’s label cautioned patients and healthcare providers to watch for new signs of compulsive behavior:
“because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole […] consider dose reduction or stopping the medication if a patient develops such urges.”
Abilify’s manufacturers now warn patients and providers of the drug’s link to compulsive behavior. It’s troubling, however, that this warning was only released in 2016. The drug’s labels in Europe and Canada have carried warnings about these side effects for years.
Outside US, Abilify Gambling Warnings Added Earlier
European regulatory authorities forced Otsuka Pharmaceutical Co. to add information on a risk of compulsive gambling back in 2012. That November, Otsuka was ordered to add an entry on pathological gambling to the drug’s Special Warnings and Precautions for Use section: “post-marketing reports of pathological gambling have been reported among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling.”
Three years later, Canadian health officials took a similar measure, after a review of the relevant medical literature substantiated “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.” A warning to that effect was added to Abilify’s Canadian labeling in November 2015.
Manufacturers Failed To Warn, Plaintiffs Say
Why, then, did it take so long for a warning to appear on the drug’s US label?
This is the pointed question asked in hundreds of recently-filed product liability lawsuits, which accuse Otsuka and Bristol-Myers Squibb of concealing Abilify’s potential risks from patients and the healthcare community. “Defendants knew or should have known that Abilify can cause compulsive behaviors like gambling,” the plaintiffs write in court documents. “Defendants failed to fully and adequately test or research Abilify and its association with compulsive behaviors.”
What Is Gambling Disorder?
Recognized first as a psychological disorder in 1980, pathological gambling is characterized by a “persistent and recurrent problematic gambling behavior leading to clinically significant impairment or distress.” Now known as “gambling disorder,” the condition is diagnosed when a patient experiences four or more of the following consequences, outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (or DSM-V), within any one year:
- Needs to gamble with increasing amounts of money in order to achieve the desired excitement
- Is restless or irritable when attempting to cut down or stop gambling
- Has made repeated unsuccessful efforts to control, cut back, or stop gambling
- Is often preoccupied with gambling (e.g., having persistent thoughts of reliving past gambling experiences, handicapping or planning the next venture, thinking of ways to get money with which to gamble)
- Often gambles when feeling distressed (e.g., helpless, guilty, anxious, depressed)
- After losing money gambling, often returns another day to get even (“chasing” one’s losses)
- Lies to conceal the extent of involvement with gambling
- Has jeopardized or lost a significant relationship, job or educational or career opportunity because of gambling
- Relies on others to provide money to relieve desperate financial situations caused by gambling
While gambling disorder was once considered an impulse-control condition, it’s now lumped in with substance abuse disorders to reflect our growing understanding of its neuro-cognitive underpinnings.
Causal Mechanism: Dopamine & Compulsion
Current research suggests that compulsive gambling behaviors are mediated by many of the same neurological reward systems that drive drug abuse. And dopamine, the same neurotransmitter acted upon by Abilify, is at the center of these reward pathways.
In fact, a report from Otsuka issued in 2011 even noted a study, The Neural Circuitry of Reward and Its Relevance to Psychiatric Disorders, in which researchers from Dartmouth University proposed a “possible mechanism by which drugs that act on dopamine neurons, like aripiprazole, might possibly have some effect on behavior related to reward.”
Abilify Patients Describe Uncontrollable Urges, Financial Ruin
“Some effect,” plaintiffs say, is an understatement. In their lawsuits, former Abilify patients claim the drug led to compulsive gambling that ruined their financial and emotional lives.
One plaintiff, whose story was published in the Daily Beast, says she was prescribed Abilify for symptoms of post-traumatic stress disorder that began after her father’s death. Soon after beginning the drug, she developed an “insatiable hunger for gambling.” She would drive hours, often late at night, to the casinos in Cripple Creek, a small mining outpost now famous for its gaming attractions in Colorado. “I started going all the time,” she wrote in a letter to her attorney, made public by legal counsel. “I never even won, never came back with so much as a dime in my pocket.”
Thus began the long and painful descent into gambling addiction. Her unemployment checks were spent at the tables. She pawned her husband’s tools to feed her compulsion, “lied about needing money to buy baby formula” and filled the hours when she wasn’t at the casino with scratch tickets. Like this woman, most of the patients who have now filed civil lawsuits say they lost more than $75,000, along with their financial security and mental autonomy, to the gambling addiction they blame on Abilify.
MDL Consolidates Nearly 600 Cases
As of January 12, 2018, 568 Abilify lawsuits are pending in the US District Court for the Northern District of Florida. The cases have been consolidated as a Multi-District Litigation, which allows similar lawsuits from across the country to be centralized in a single federal court. The Honorable Margaret Casey Rodgers, the Court’s Chief District Judge, has been tapped to preside over the litigation.
The process of discovery, in which evidence is gathered, is now underway. In one of the case’s latest updates, Judge Rodgers gave the go-ahead for several high-level employees at Otsuka Pharmaceutical to be deposed at the US Consulate in Osaka, Japan.