Abilify Lawsuit

The Abilify lawsuit is against the manufacturer for failure to warn about the risk of compulsive gambling. Abilify is manufactured by Bristol-Myers Squibb. The lawsuits allege that Bristol-Myers Squibb failed to warn both the patients and their prescribing physicians about the risk that Abilify could trigger compulsive behaviors, such as gambling, even in those with no previous compulsive behaviors. Abilify attorneys argue that the patient’s psychiatrist would have monitored the patient closer and asked questions to ensure that the patient was not developing compulsive behaviors. Additionally, had proper warnings been provided, the patient and the patient’s family members would have known to be on the lookout for potential signs and symptoms of compulsive gambling. Abilify is considered an antipsychotic medication and is prescribed for the treatment of depression, bipolar disorder, schizophrenia, Tourette syndrome, and at times has even been prescribed to treat the irritability associated with autism. All Abilify lawsuits filed in Federal court have been consolidated in a multi-district litigation (MDL) in the United States District Court, Northern District of Florida – Pensacola Division, in front of Judge M. Casey Rodgers.

About Abilify

Abilify, also known by its chemical name aripiprazole, was originally developed by Otsuka Pharmaceutical Co., Ltd. Bristol-Myers Squibb later partnered with Otsuka Pharmaceutical to co-develop and commercialize Abilify. In 2002, Abilify hit the US market and quickly became the a top-selling antipsychotic drug. Abilify is most commonly prescribed for schizophrenia, bipolar, and depression. No other US Food and Drug Administration-approved antipsychotic acts on the dopamine system (the body’s reward center) in the manner that Abilify does. Because of Abilify’s unique mechanism of action on the dopamine system, users can develop strong, irresistible urges, such as urges to constantly gamble, shop, or have sex. The compulsive urges can become so strong that users will destroy their entire lives in order to fulfill the urge. Upon fulfilling the compulsive urge, such as gambling, many users will experience euphoria, which results in repetitive compulsive behavior. Winning at gambling won’t fulfill the urge, losing at gambling won’t fulfill the urge, the urge can only be momentarily satisfied while actually gambling.

Abilify Side Effects2mg green Abilify tablet

Severe Impulsiveness- Committing action without foresight. Severe impulsiveness or compulsiveness caused by Abilify puts the user in danger of:

  • Compulsive Gambling
  • Risky Sexual Behavior
  • Compulsive Shopping
  • Drug Use
  • Addiction
  • Violent Behavior
  • Committing Crime
  • Suicide

Abilify Compulsive Gambling Adverse Events Reported to the FDA

A search within the FDA’s Adverse Events Reporting System (FAERS) returns 53 adverse event reports from April 7, 2015 through August 31, 2017, for Abilify induced “Obsessive-Compulsive disorder; Gambling Disorder.”

Abilify FDA Adverse Events on Compulsive Gambling

However, not every doctor uses the specific code “Obsessive-Compulsive Disorder; Gambling Disorder” when they enter the adverse event report. Another search in the FDA’s FAERS database on all adverse reactions to Abilify returns 34,346 results! Of the first 12 results for Abilify adverse reactions, 5 of them are related to compulsive gambling! An even closer look reveals that 3 of the 5 reports regarding gambling resulted in the patient committing or attempting suicide.

Abilify Compulsive Gambling Disorder

Our Abilify attorneys believe that a large number of adverse events related to Abilify are going unreported, because many patients and psychiatrist are still unaware of the link between Abilify and compulsive gambling. If you or a loved one are taking Abilify, be aware of the signs and symptoms of compulsive gambling.

Signs of Abilify-Induced Compulsive Gambling

  • Trouble controlling gambling habits
  • Hiding how often of how much you are gambling from others
  • Gambling when you can not afford to lose money
  • Family or friends comment on the extent you are are gambling

Symptoms of Abilify-Induced Compulsive Gambling

  • Depression
  • Anxiety
  • Sleep deprivation
  • Weight gain or loss
  • Dark circles under the eyes

Were the Manufacturers of Abilify Aware it Could Cause Compulsive Behavior?

Early trials of Abilify identified that the drug could result in hypersexuality, a form of compulsive behavior. However, the Abilify warning label did not did not prominently warn of compulsive gambling or compulsive behavior in general.

Abilify Warning Label: Hypersexuality

Other Countries Were Warned That Abilify Could Case Pathological Gambling?!?

Europe Warning Label

In October of 2012, the warning label for Abilify was updated in Europe to include a special warning that Abilify could cause pathological gambling. The warning even notes that patients with no prior history of gambling could develop pathological gambling. The warning also indicates that those with a history of pathological gambling may be at an even greater risk of developing more severe gambling habits. However, the United States Food and Drug Administration did not mandate a warning update regarding Abilify and compulsive gambling at this time. Who exactly is the FDA protecting?

Pathological Gambling Warning on European Abilify Label

Canada Warning Label

On November 2, 2015, Health Canada performed a review of adverse event reports and literature and concluded that “there is a link between the use of airpiprazole (Abilify) and a possible risk of pathological gambling or hypersexuality.” Health Canada noted that “after the totality of the evidence was considered, and because of the extensive use of Abilify, Health Canada has updated the Canadian prescribing information for Abilify and Abilify Maintena with the addition of a warning statement for the risk of pathological gambling and the inclusion of hypersexuality as a reported side effected.”

US FDA Action Regarding Abilify and Compulsive Gambling

United States Warning Label

Finally, in January 2016, the Abilify warning label in the United States was updated to included pathological gambling. However, the new Abilify warning label did not feature a prominent black box warning, it wasn’t really even a warning… it was buried pages deep in the “postmarketing experience” section. The warning label even downplays the association between Abilify and pathological gambling by stating a causal relationship could not be established. The United States Abilify warning change was not prominent enough to alert any patient or physician of the true risk of compulsive gambling associated with Abilify.

Abilify warning label for pathological gambling in the United States

United States Safety Announcement

On May 3, 2016, the U.S. Food and Drug Administration issued a safety announcement alerting consumers and physicians that Abilify could trigger “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.” The FDA also noted that “These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient or others if not recognized.” The FDA confirmed that there were already 184 case reports identified of Abilify resulting in compulsive behaviors. The FDA went on, adding that “in the majority of case reports patients with no prior history of the compulsive behaviors experienced uncontrolled urges only after start [Abilify] treatment. Within days to weeks… discontinuing [Abilify], these uncontrolled urges stopped.”

FDA Safety Announcement Abilify Impulse Control

United States Second Warning Label Update

On August 18, 2016, the Abilify warning label in the United States was updated to include pathological gambling and other compulsive behaviors in the warnings and precautions section. However, there is still no black box warning on Abilify causing pathological gambling, which is the most prominent warning, .

Abilify Warning and Precautions: Pathological Gambling and Other Compulsive Behaviors

Can We Prove that Abilify Causes Compulsive Gambling?

Causation is a large aspect of any lawsuit, including any Abilify lawsuit that goes to trial. The gold standard for causation in a drug injury case is something called a dechallenge. A dechallenge is when symptoms didn’t begin until the drug was started and the symptoms go away once the drug is discontinued. The European Medical Association (EMA) reviewed medical literature and found that all cases of reported gambling associated with Abilify began after Abilify was started and resolved after Abilify was discontinued. Do not stop any medication, including Abilify, without first consulting a physician.

European Medical Association determines Abilify causes pathological gambling

Scientific Articles on Abilify and Compulsive Behavior

Jun 2017: Classics in Chemical Neuroscience: Aripiprazole (Abilify)

 The authors note that the receptor (5-HT2B) to which Aripiprazole (Abilify) has the highest affinity to, has been linked to impulsivity both preclinically and clinically. The authors found this link intriguing, because of previous reports of serious impulse control deficits and compulsive behaviors in groups of patients taking Abilify. The authors conclude that “although immediate focus moved to [Abilfiy’s] dopamine agonist activity, [Abilify’s] highly potent inverse agonist activity at 5-HT2B receptors may also contribute to impulsive and compulsive behavior.”

Feb 2017: Risk of Gambling Disorder and Impulse Control Disorder with Aripiprazole, Pramipexole, and Ropinirole: A Pharmacoepidemiologic Study

The study authors decided to look into the association between Abilify and compulsive gambling because of the recent US Food and Drug Administration’s warning on the potential risk of gambling disorders while taking Abilify. The authors noted that even though there was an FDA warning, large epidemiologic studies were lacking. The study compared at 355 cases of gambling disorder to a control of 3,550 people. The study also compared 4,341 cases of impulse control with a control of 43,410 people. After adjusting for cofounders, users of Abilify demonstrated an increased risk of pathologic gambling. The authors noted that their study confirmed an association between Abilify and impulse control disorder and gambling disorder.

Feb 2017: Obsessive-Compulsive Symptoms Associated with Aripiprazole (Abilify) Treatment in Bipolar Disorder: A Case Report

The study looks at second-generation antipsychotics (SGAs), such as Abilify and how obsessive-compulsive symptoms can develop.

Dec 2016: Induced Obsessive Compulsive Symptoms (OCS) in Schizophrenia Patients under Atypical 2 Antipsychotics (AAPS): Review and Hypotheses

“The prevalence of OCS (obsessive-complusive symptoms) and OCD (obsessive-compulsive disorder) is higher in schizophrenic patients than in the general population. These disorders are sometimes induced by AAPS (Atypical 2 Antipsychotics). Abilify is an AAPS.

Jun 2016: Aripiprazole, Gambling Disorder and Compulsive Sexuality

A 28-year-old male was started on 15 mg of Abilify. The patient then “developed an addiction habit for gambling at casino slot machines. Due to large gambling debts, he requested placement on a voluntary self-exclusion list. Thereafter, he turned his attention towards scratch card gambling. The patient described his experience of gambling as a “hypnotic state.” He got several personal loans to obtain money to continue gambling. He was then referred to an addiction unit. Before being treated with aripiprazole (Abilify), he was exclusive heterosexual with a poor sexual activity. Under treatment, he switched to homosexual behavior with hypersexuality, unprotected sex and sadomasochistic practices. The craving for gambling and compulsive sexual behavior ceased two weeks after Abilify was discontinued…. He reported a return to a heterosexual orientation.” The authors conclude that “these side effects are little known, They are usually difficult for patients to mention due to feelings of guild. The consequences on social life, family and health may be serious. Clinicians and patients should be aware about the possible issue of these behavior disorders with Abilify.”

Feb 2016: Pathological Gambling Associated with Aripiprazole or Dopamine Replacement Therapy

A review of French with a gambling disorder revealed 48 cases where the gambling disorder might have been caused by drug working on the dopamine system. 17 of the gambling disorder cases were noted to be on the drug Abilify. The authors of the study noted that those who developed a gambling disorder on Abilify seemed to be more severe pathological gamblers than those who were taking other drugs that worked on the dopamine system.

Nov 2015: Mice Lacking Serotonin Htr2B Receptor Gene Present an Antipsychotic-Sensitive Schizophrenic-Like Phenotype

The authors discuss how impulsivity, hyperactivity, and numerous mental disorders share common ground. One example was of 5-HT2B mutant mice which showed high impulsivity, psychosis, and early-onset schizophrenia. 5-HT2B is the receptor that Abilify works on.

Dec 2014: Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated with Dopamine Receptor Drugs

The authors conclude that “none of the dopamine receptor agonist drugs approved by the FDA have boxed warning about the potential for the development of severe impulse control disorders as part of their prescribing information. Our data, and data from prior studies, show the need for these prominent warnings. Physicians who prescribe dopamine agonists should also vigilantly monitor their patients, and ensure that patients, families, and caregivers are counseled about the risk of these serious adverse events.”

Mar 2014: Aripiprazole: A New Risk Factor for Pathological Gambling? A Report of 8 Case Reports

166 pathological gamblers began treatment. It was discovered that 8 of the pathological gamblers were taking Abilify. The authors note that the “dopamine partial agonist mechanism of [Abilify] could explain the occurrence of pathological gambling.”

Feb 2014: Atypical Neuroleptics; Compulsive Disorders

The article notes that atypical neuroleptics such as Abilify have been implicated in cases of pathological gambling, hypersexuality, and compulsive eating and shopping, with sometimes serious social and familial consequences. When the drug such as Abilify was withdrawn or replaced, the compulsive disorders improved or ceased. The author warns that “patients must be informed of these possible adverse effects and monitored for behavioral changes. If such disorders occur they can be managed by withdrawing the drug, reducing the dosage, or switching to another neuroleptic.”

Jul 2011: Pathological Gambling and the Treatment of Psychosis with Aripiprazole: Case Reports

A study of three male patients, aged 29, 28, and 26 that were taking Abilify. All three patients reported that they started gambling or had a dramatic escalation in their gambling after starting Abilify. One patient reported that 3 months after start Abilify, he began “spending all of his money and it being a reason to live.” Another patient that had never gambled before taking Abilify reported experiencing “strong urges to gamble in the form of a euphoric feeling when thinking about gambling.” The third patient expressed that he was “pre-occupied with thoughts of gambling and his gambling activity became both impulsive and involved extensive planning in obtaining funds to gamble, including the use of crime.” All three patients felt no compulsion to gamble after Abilify was discontinued. The authors concluded that “the need for additional research and for vigilance in its use with individuals exhibiting a history of impulse control-related difficulties.”

Feb 2011: Aripiprazole-Induced Pathological Gambling: A Report of 3 Cases

Three patients with schizophrenia or schizoaffective disorder with no previous history of pathological gambling were started on Abilify. All three patients developed pathological gambling induced by Abilify. Pathological gambling in all three patients disappeared quickly after Abilify was discontinued. The even noted that because “pathological behaviour disappears quickly as medication was ended suggests that an elaborate behavioral manifestation could be related to dopaminergic tone in patients with schizophrenia We recommend consideration with increased attention for the appearance of pathological gambling symptoms among patients on Aripiprazole (Abilify).”

Dec 2010: A Population-Specific HTR2B Stop Codon Predisposes to Severe Impulsivity

The authors found that those with a mutant HTR2B (receptor that Abilify works on) demonstrated increased impulsive behaviors. The authors note that “Despite [SGAs] effectiveness in OCD, there are many contradictory reports of OCD being worsened or associated with SGAs…” The authors went on to note that there were already case reports surfacing of Abilify being associated with obsessive-compulsive disorder (OCD).

Mar 2010: Pathological Gambling and Compulsive Eating Associated with Aripiprazole

A 64-year-old women was started on 10 mg of Abilify and then increased to 15 mg daily. The patient “developed an irresistible urge to gamble, losing up to AUD$700 per session, which she could ill afford. She also experienced a compulsion to eat.” The patient described her experience as “I just wanted to keep putting money in, it was an urgency, I would go high…… and I seemed to lose all reason. I also could not say no to food, especially sweets and cakes.” The authors of the study suggest that “clinicians should ask about compulsive behavior with this antipsychotic, because patients may be reluctant to disclose this voluntarily.”

Jun 2007: Aripiprazole-Induced Obsessive-Compulsive Disorder: A Report of 2 Cases

The authors note that Abilify is a new generation atypical antipsychotic that is considered a “dopamine system stabilizer.” The authors could find no prior reports of Abilify inducing compulsive disorders, but report on two of their patients that they believed developed obsessive-compulsive symptoms due to Abilify.

Abilify Lawsuit

Have you or a loved one taken Abilify and developed compulsive behaviors, such as compulsive gambling. If so, contact the Hollis Law Firm at 1-800-701-3672 to speak to one of our Abilify lawsuit intake specialist today. All case reviews are confidential and carry no risk or obligation. The Hollis Law Firm works on a contingency fee basis, which means we only get paid if you get paid. Additionally, call your doctor and make them aware of your Abilify related symptoms before discontinuing any medication. A list of state specific gambling addiction hotlines can be found here at Gamblers Anonymous.

Content Created By:

C. Brett Vaughn RN, BSN, JD