(Updated March 13, 2018)
Abilify (aripiprazole) is an antipsychotic drug used to treat disorders such as schizophrenia, bipolar disorder, and depression. Advertisements for Abilify say that the drug works “like a thermostat to restore balance” in the brain, but nobody—including drugmakers and the FDA—knows exactly how Abilify works.
While its mechanism of action remains poorly understood, a growing body of evidence suggests that the way Abilify affects the brain can cause compulsive behavior, including compulsive gambling. This has led to financial losses and lawsuits.
A growing body of evidence suggests that Abilify can cause compulsive behavior.
Direct-to-consumer advertising helped to make Abilify the top-selling drug in America, but until 2016 product literature for U.S.-sold Abilify did not warn about compulsive gambling and other impulse control problems. Europe and Canada, on the other hand, had started including warnings on Abilify packages years earlier.
Patients who suffered significant gambling losses while taking Abilify are now suing maker Otsuka Pharmaceuticals. If you took Abilify and began to gamble uncontrollably, you may have a case. Contact us for a free consultation to find out if you qualify for compensation.
A Brief History of Abilify
Abilify was developed by Japanese drugmaker Otsuka Pharmaceuticals and marketed in the U.S. through a partnership with Bristol-Myers Squibb.
The drug was developed as a treatment for schizophrenia and gained initial FDA approval for this use in 2002. A few years later, Abilify was FDA-approved to treat bipolar disorder. In 2007, the FDA approved Abilify as an add-on to other medications to treat major depressive disorder.
Prior to that, the drug’s makers were seeking to expand Abilify sales through new but unapproved uses. In 2007, the Justice Department hit Bristol-Myers Squibb with a $515 million fine for marketing Abilify “off-label” to children, adolescents, and geriatric dementia patients.
But it was only after Abilify could be prescribed for depression that sales began to soar. Combined, bipolar and schizophrenia affect only about 2.5% of Americans and represent a very limited market. Depression affects 16 million Americans, or 6.9% of the population.
Once Abilify was approved to treat depression, its sales exploded, due in large part to a major direct-to-consumer, $121 million per year advertising campaign that has been criticized for being over-simplistic.
By 2013-2014, Abilify was the top-selling drug (in terms of sales) in the U.S. From October 2013 to September 2014, Abilify had sales of $7.5 billion—more than all the other major anti-depressants combined.
Over this same period, dozens of patients complained to the FDA about compulsive behavior associated with Abilify. From 2005 to 2014, at least 59 cases of compulsive gambling were reported to the FDA. In just the first half of 2015, the FDA received more than 150 reports related to Abilify and gambling.
That same year, the FDA sent a letter to Otsuka saying its claims about Abilify were scientifically unsupported.
European and Canadian health authorities looked at the scientific evidence linking Abilify to compulsive behaviors and enacted new warning labels for this potential side effect (Europe did so in 2012, and Canada in 2015). The FDA ordered compulsive behavior warnings to be added to U.S.-sold Abilify in 2016.
In the first half of 2015, the FDA received more than 150 reports related to Abilify and gambling.
Patients are now filing lawsuits against the drug’s manufacturers, claiming that they suffered significant gambling losses while taking Abilify, and that the prior lack of a warning for this side effect constitutes a marketing defect.
Otsuka lost its U.S. Abilify patent in May 2015, setting the stage for a major sales decline as additional manufacturers begin to offer generic versions of the drug.
How Does Abilify Work?
Abilify mimics the effects of dopamine in the brain. Dopamine is an important neurotransmitter that helps regulate the brain’s reward and pleasure centers. Psychology Today explains that dopamine helps regulate emotional responses, enabling people “not only to see rewards, but to take action and to move toward them.”
It is only generally understood how Abilify regulates brain chemistry and helps to alleviate brain disorder symptoms. It is therefore also unknown exactly how the drug might cause compulsive gambling and other compulsive behavior.
Abilify mimics the effects of dopamine in the brain.
Deficient levels of dopamine can cause depression, while excessive dopamine levels can lead to psychosis and dysfunction. Abilify helps to regulate mood by striking the right balance of dopamine—not too much, and not too little. Or, as a heavily aired Abilify TV commercial put it, the drug works in the brain “like a thermostat to restore balance.” A print advertisement put it another way: “When activity of key brain chemicals is too high, Abilify lowers it. When activity of key brain chemicals is too low, Abilify raises it.”
Critics have pointed out that these advertising claims, while compelling, are debatable. The workings of the brain are poorly understood, and the causes of mood disorders—even those as prevalent as depression—are unknown.
It shouldn’t be surprising, then, that Abilify’s mechanism of action is also unknown. Indeed, that’s precisely the phrasing used in the drug’s insert: “The mechanism of action of aripiprazole… is unknown.”
How Safe Is Abilify?
After Abilify was approved for depression, and as sales began to surge, Otsuka admitted in a benefit-risk evaluation report covering the period 2012-2013 that the safety and efficacy of aripiprazole as an add-on to depressants hadn’t been evaluated in long-term controlled trials (the gold standard of clinical trials).
"There is limited evidence that Abilify leads to symptom reduction when added to antidepressants."
Another study concluded, “There is limited evidence that Abilify leads to symptom reduction when added to antidepressants and side effects are more frequent under Abilify augmentation treatment.” And a review of all the randomized clinical trials comparing Abilify to other schizophrenia drugs concluded that the information on comparisons was of limited quality, incomplete, and problematic to apply clinically.
Meanwhile, Otsuka continued to promote the drug as superior to competitors, despite the lack of scientific support for this claim. The FDA took the drugmaker to task for this in a 2015 letter, where it wrote that “the totality of these claims and presentation is… misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or [depression] when this has not been demonstrated.”
In December 2016, Bristol-Myers Squibb reached a $19.5 settlement with the U.S. Justice Department over its unlawful marketing of Abilify and its downplaying of the drug's myriad risks.
Did Otsuka Pay Doctors to Promote Abilify?
In addition to promoting Abilify for off-label uses—and promoting the drug for approved uses through oversimplified and misleading advertising claims—Otsuka Pharmaceuticals also paid doctors to promote the drug.
According to ProPublica, more than 21,500 doctors have received $10.6 million in payments related to Abilify.
Has Abilify Been Linked to Compulsive Behaviors?
Numerous studies link Abilify to compulsive gambling and other compulsive behaviors, such as hyper-sexuality, binge eating, and binge shopping. European and Canadian authorities evaluated the scientific evidence on Abilify and compulsivity and found that it warranted updated safety labeling.
The EU added warnings in 2012, and Canada followed suit in 2015. In the U.S., however, Abilify labeling did not even mention the word "gambling" until January 2016--more than 13 years after the drug was approved, while warnings about binge eating, shopping, and sex were not added until May 2016.
Numerous studies link Abilify to compulsive gambling and other compulsive behaviors, such as hyper-sexuality, binge eating, and binge shopping.
FDA regulations require a warning when there is “reasonable evidence” of a causal association between a drug and a side effect. In the case of Abilify, there is evidence dating back to 2009 that links dopamine agonists to compulsive behavior, while aripirazole has specifically been linked to compulsive behaviors since at least 2010.
A selection of study findings demonstrates the possible causal relationship between Abilify and compulsive behavior. For example:
- “We report 3 cases of Aripiprazole-induced pathological gambling.” (Cohen, et al., “Aripiprazole-induced pathological gambling: a report of three cases”, Current Drug Safety 2011; 6: 51-53)
- “The observations do, however, indicate an association between aripiprazole and a reduction in the impulse control relating to their behaviour.” (Neil Smith et al., Pathological Gambling and the Treatment of Psychosis with Aripiprazole: Case Reports, 199 British J. of Psychiatry 158, 158-59 (2011) (3 Cases)
- “clinicians should ask about compulsive behaviour with this antipsychotic” (Milton G. Roxanas, Pathological Gambling and Compulsive Eating Associated with Aripiprazole, 44 Australian & New Zealand J. of Psychiatry 291, 291 (2010)
Strengthening the association between Abilify and compulsive gambling is this observation by Health Canada: “Among 14 of the 18 international cases of compulsive gambling identified in a review of the scientific and medical literature, the behaviours resolved or improved when the treatment with aripiprazole was stopped or the dosage was reduced.”
Why Did the FDA Order More Abilify Warnings?
In May 2016, the FDA warned about impulse control problems associated with Abilify, noting that the drug is associated with "uncontrollable urges to gamble, binge eat, shop, and have sex" and announcing the addition of new warning labels about these compulsive behaviors.
Patients with no prior history of compulsive behaviors experienced uncontrollable urges only after starting Abilify treatment.
The agency cited nearly 200 case reports of aripiprazole and impulse-control problems, most of them related to compulsive gambling. Importantly, the FDA points out that patients with no prior history of the compulsive behaviors experienced uncontrollable urges only after starting Abilify treatment. Soon after reducing the dose or discontinuing the drug, these uncontrollable urges went away.
Abilify-related impulse control problems, says FDA, may result in harm to the patient and others if not recognized. The FDA encourages patients who experience impulse control problems while taking Abilify to contact their health care provider.
What Do Abilify Lawsuits Allege?
Our attorneys are now filing Abilify lawsuits alleging that Otsuka and Bristol-Myers Squibb knew—or should have known—that Abilify can cause compulsive behaviors such as compulsive gambling. Furthermore, we feel their failure to warn of this potential side effect has caused some patients to gamble uncontrollably and suffer economic hardship, emotional distress, and other losses.
If you or someone you know took Abilify and experienced compulsive gambling that resulted in significant financial losses, you may be able to seek compensation through a lawsuit. Contact us today to learn your rights.