Morgan & Morgan is investigating lawsuits on behalf of patients who were prescribed the drug Abilify (aripiprazole) and developed compulsive gambling behaviors.
Abilify, used to treat major depression, bipolar disorder, and schizophrenia, is the top-selling antipsychotic medication in the United States. But due to how the drug affects the brain, patients may develop a problem with impulse control that causes them to gamble uncontrollably.
European and Canadian health officials found the association between Abilify and compulsive gambling strong enough to warrant updated product labeling to warn about this risk. Despite this, drug makers Bristol-Myers Squibb and Otsuka Pharmaceuticals have chosen not to include a similar warning on Abilify sold in the U.S.
Compulsive gambling can lead to psychological distress, health problems, financial harm, and social consequences. An Abilify compulsive gambling lawsuit could provide compensation for these losses.
The Problem With Abilify
Clinical trials for aripiprazole showed compulsivity—in particular, hypersexuality—as a potential undesirable effect of the drug. At the time this finding was quite unremarkable. But in hindsight it fits a pattern of Abilify users developing impulsive behaviors not previously exhibited once they began taking the drug.
This pattern gained wider attention in 2012 when the European Medicines Agency demanded that a new warning label be added to Abilify addressing the drug’s connection to “pathological gambling.” The updated label was based on post-marketing studies that showed 19 cases of pathological gambling among Abilify users. Most cases met the criteria for “serious.”
The new European Abilify warning states that:
- 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.
Following in the footsteps of EMA, Health Canada took a similar measure in 2015 when it issued updated Abilify based on a safety review that found an increased risk not only of uncontrollable gambling, but also hypersexuality (uncontrollable and/or inappropriate sexual thoughts, urges or behaviors).
The new Health Canada Abilify gambling warning reads:
- Post-marketing reports of pathological gambling have been reported in patients treated with ABILIFY. In relation to pathological gambling, patients with a prior history of gambling disorder may be at increased risk and should be monitored carefully.
Significantly, Health Canada noted in its safety review that in 14 of the 18 gambling cases and 5 of 6 of the hypersexuality cases that it studied, the patients resolved or improved their compulsive behaviors when they stopped taking Abilify or reduced their dosage.
But in spite of these revised warnings and the scientific literature supporting them, the labeling for Abilify sold in the U.S. makes no mention that pathological gambling has been reported in Abilify patients. Indeed, the word “gambling” is mentioned nowhere on the labeling for U.S.-sold Abilify.
From 2005 to 2013 at least 54 cases of compulsive or impulsive behavior problems associated with Abilify, including 32 reports of compulsive gambling, were reported to FDA. In 2014, 29 Abilify gambling behavior reports were submitted to FDA. In the first half of 2015 alone, 153 such FDA reports were received. Due to severe reporting of adverse events, the actual number of Abilify compulsive/impulsive behavior problems are likely much higher.
Drug companies have an obligation to inform the public of potential side effects. Yet, even with everything the manufacturers knew and with warnings from the Canadian and European health agencies, pathological gambling is not listed on the label as a possible side effect in the U.S. We believe this has resulted in wrongful and unjust profit made at the expense of patient safety.
Bristol Myers Squibb announced $2.3 billion in sale for Abilify in 2013, making it the company’s best selling drug. More recently, BMS announced $417 million in U.S. revenue from Abilify over the course of three months ending June 30, 2014. During that same time worldwide sales of the drug were comparably small at just $555 million.
Studies Supporting Abilify’s Gambling Link
Compulsive gambling can lead to psychological distress, health problems, financial harm, and social consequences.
There are numerous reports of compulsive behaviors in Abilify users in medical literature.
The most recent, “Pathological Gambling Associated With Aripiprazole or Dopamine Replacement Therapy,” looked at 17 cases of gambling disorder possibly related to aripiprazole and found that in 16 of 17 cases, it was possible that the drug caused the gambling. The researchers also found more severe gambling with Abilify than with dopamine replacement therapy (a similar medication).
Other studies linking Abilify to compulsivity include:
- Aripiprazole: a new risk factor for pathological gambling? A report of 8 case reports. (2013)
- Two Cases of Hypersexuality Probably Associated with Aripiprazole. (2013)
- Partial agonist therapy in schizophrenia: relevance to diminished criminal responsibility. (2010)
- Pathological gambling and compulsive eating associated with aripiprazole. (2010)
How Can Abilify Cause Compulsive Gambling?
It’s not perfectly understood how Abilify might cause compulsive behaviors such as uncontrollable gambling, but the connection between drugs like Abilify and reward seeking such as gambling are well-documented in scientific literature.
Abilify is a type of drug known as a “dopamine agonist” that imitates the effects of dopamine in the brain. Dopamine is a chemical that plays a key role in controlling the brain’s award and pleasure centers. It also plays an important role in addiction.
Abilify, some researchers believe, affects the brain’s dopamine system in two ways: creating urges towards reward and impairing decision-making. Thus, the drug might both hyper-stimulate the brain’s reward system and reduce cognitive control (in other words, press the accelerator while disarming the brakes).
Mirapex (pramipexole), a drug used to treat Parkinson’s disease, and Abilify are not in the same class, but they are both dopamine agonists. Lawsuits in the United States, Canada, and Australia were filed over Mirapex and compulsive gambling. One U.S. case, filed by a man who allegedly suffered $260,000 in gambling losses after he began taking the drug, settled for $8.3 million.
Abilify, some researchers believe, affects the brain’s dopamine system in two ways: creating urges towards reward and impairing decision-making.
DOJ Abilify Settlement for Illegal Drug Marketing
Abilify maker Bristol-Myers Squibb paid more than $515 million in 2007 to settle accusations that it paid kickbacks to healthcare professionals to promote its drugs, promoted Abilify “off label” for uses not FDA approved, and other illegal practices. Otsuka Pharmaceuticals later paid an additional four million to resolve allegations.
In April 2015, the FDA issued a letter which stated Abilify’s promotional material as “false or misleading because it makes misleading claims and presentations about the drug.” The FDA found the material “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.”
The FDA also found the cited references “not sufficient to support claims and presentations suggesting that Abilify has been demonstrated to modulate dopaminergic and serotonergic activity, or modulate neuronal activity in both hypoactive and hyperactive environments in humans.”
According to the Department of Justice, Bristol-Myers Squibb directed its sales force to promote Abilify for children, adolescents, and elderly patients. The sales force tried to drum up business in nursing homes for patients suffering from dementia-related psychosis even though the FDA mandated that Abilify packaging contain a “black box” warning over its use in the treatment of dementia-related psychosis.
How to File an Abilify Lawsuit
To date, the manufacturers of Abilify have yet to notify patients, the medical community, or prescribers in the U.S that Abilify is linked to pathological gambling. Compulsive behavior is not listed as a possible side effect on the drug’s label, nor its website.
Bristol-Myers Squibb and Otsuka Pharmaceuticals knew or should have known about this possible side effect and warned patients. Their failure to provide accurate product labeling put thousands of patients unnecessarily at risk of engaging in risky behaviors such as compulsive gambling.
If you developed a gambling problem after beginning treatment with Abilify, have no prior history of compulsive gambling, and suffered significant gambling losses, you may be eligible for legal action.
Our attorneys at Morgan & Morgan have a strong track record of fighting and beating large pharmaceutical companies and medical device makers that have taken advantage of the public through class action lawsuits. If you would like to find if you are eligible for compensation, please contact us for a free case review.