In Re: Abilify (Aripiprazole) Products Liability Litigation

Abilify is an antipsychotic medication that functions by either increasing or decreasing dopamine or serotonin when an imbalance is present. It is part of a class of drugs known as partial dopamine receptor agonists that imitate the effects of dopamine to the brain.[1] The dopamine system keeps humans alive by ensuring that we continue to eat and maintain other basic needs.[2] The dopamine system works by sending a signal of pleasure to the brain in response to certain activities,[3] which plays an important role in addiction.[4] People with mental illnesses often have imbalanced dopamine systems that are either overly stimulated or not stimulated enough.[5]

The FDA approved Abilify in November 2002 for the treatment of schizophrenia, bipolar disorder, major depressive disorders, irritability, aggression, mood swings and other behavioral issues.[6] It is not approved for use for psychotic conditions related to dementia.[7] Within years of its introduction onto the American market, Abilify became one of the best selling antipsychotic medications in the country and was the top selling drug for Bristol Myers.[8] Abilify generated $5.5 billion in revenue in 2013 and $2.02 billion in revenue in 2014.[9] In 2015, Abilify’s patent expired in both the U.S. and Europe, contributing to a dip in profits.

Published side effects on the label of Abilify include fever, stiff muscles, sudden nausea, dry skin, and thoughts of suicide or self-mutilation.[10] Not long after its introduction into the American market, patients reportedly experienced intense compulsive behavior while using Abilify, manifesting itself in hyper-sexuality and compulsive gambling. The FDA received 54 FAERS reports of compulsive behaviors linked to Abilify between 2005 and 2013, 29 reports in 2014 and 153 reports in the first half of 2015, alone.[11]

Studies examining the links between Abilify and compulsive behavior began as early as 2008 when an Australian study revealed that patients taking Abilify to treat schizophrenia began to experience strong sexual urges that quickly developed into a sex addiction.[12] Patients in the study reported being obsessed with sexual thoughts, feelings and behaviors, despite reporting little to no sex drive before taking Abilify. The following year, the Mayo Clinic conducted a study of patients who were prescribed dopamine receptor agonist medications and found that participants in the study exhibited unusually high rates of compulsive behaviors including pathological gambling and hypersexual behavior.[13]

In 2011, British researchers at the National Problem Gambling Clinic observed a link in study participants who were taking Abilify and who exhibited a compulsive need to gamble.[14] Patients reported that the need to gamble was all consuming and would include extensive planning on how the patient would obtain the money to continue to gamble.[15] Other participants reported that gambling was their reason to live. Once patients discontinued Abilify, the compulsive behavior subsided.[16]

In 2012, The European Medicines Agency (“EMA”) ruled that Bristol-Myers Squibb and Otsuka Pharmaceuticals update the Abilify label to include information regarding the possibility of compulsive behavior when taking the drug.[17] The label now reads: “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.”[18]

In 2015, following the lead of the EMA, Health Canada similarly decided to update safety labels on Abilify to warn patients of the risk of developing compulsive behaviors.[19] The label now 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.”[20] Additionally, Health Canada did reveal that most symptoms did subside once patients ceased taking the drug.[21]

In 2014, The Journal of the American Medical Association (“JAMA”) published the results of a study, confirming the links between specific impulse control disorders and dopamine receptor agonist drugs.[22] The study examined a large pool of patients taking dopamine receptor agonist drugs and found that over 10% of patients experienced compulsive behavior; in fact, patients reported more incidents of compulsive behavior than suicidal thoughts, which is a side effect listed on Abilify’s label.[23]

In March 2016, the FDA issued a safety communication, warning both doctors and patients that the use of Abilify could cause uncontrollable urges to gamble, eat, have sex and shop.[24] The FDA stressed that while compulsive urges are a rare side effect of the drug, it can be dangerous if left untreated.[25]  The warning further stated that even though pathological gambling is listed as a possible side effect on the drug’s label, the FDA now feels that the label is no longer sufficient to warn consumers of the true severity of the possible myriad of compulsive behavioral side effects.[26]

Plaintiffs have filed lawsuits against pharmaceutical manufacturers, Bristol-Myers Squibb and Otsuka Pharmaceuticals, alleging that the companies failed to warn both doctors and patients of the possibility that patients could experience compulsive behavior as a side effect of the antipsychotic medication, Abilify (aripiprazole). Plaintiffs claim that while taking Abilify, they experienced various compulsive and uncontrollable urges such as the urge to gamble, binge eat, shop and have sex.[27] The aftermath of these serious side effects have left many Abilify users with severe debt and broken homes.

Users describe their urge to gamble as uncontrollable; they are left devoid of rational thinking, believing that they cannot live unless they gamble.[28] Plaintiffs argue that Bristol-Myers Squibb and Otsuka Pharmaceuticals should have made the public aware of these side effects before putting the drug on the market, especially since premarket testing revealed that the drug caused compulsivity, specifically, hyper-sexuality.[29] In the lawsuits, plaintiffs are requesting compensation for expenses for treatment of compulsive gambling, severe emotional injuries, and recovery of money lost to gambling.[30] As of July 2016, only individual Abilify lawsuits have been filed.