On April 13, 2004, the U.S. Food and Drug Administration (FDA) instructed Bristol-Myers Squibb to notify health care professionals of a revision to the warnings section of labeling for Abilify (aripiprazole), describing the potential increased risk of hyperglycemia and diabetes in patients taking the drug. In a recent study, atypical antipsychotics similar to Abilify were found to cause diabetes 50 percent more often than older drugs.
Abilify is used to treat schizophrenia and is part of a class of drugs known as atypical antipsychotics. It is in the same class as Zyprexa, Risperdal and Seroquel. The U.S. Food and Drug Administration approved Abilify for the treatment of schizophrenia on November 15, 2002.
The FDA has become concerned about the possibility that Ziprasidone, a drug similar to Abilify, and a number of other drugs might increase the possibility of a specific, and potentially fatal heart-rhythm irregularity called torsade de pointes.
Additional Abilify side effects include: being unusually tired, nausea, constipation, dizziness, restlessness, diarrhea, rash, cough, runny nose, abnormal muscle movements, tremors, and uncontrollable movements.
Abilify and Pathological Gambling
Research suggests that the use of Abilify could induce or worsen pathological gambling. This type of addictive behavior could potentially lead to severe financial loss, relationship issues, and legal problems. Abilify is believed to regulate mood and behavior in patients with psychosis by affecting levels of dopamine and serotonin. Researchers believe that Abilify may influence compulsive behavior by over-stimulating dopamine receptions in the brain, intensifying the reward system.
In April 2011, the British Journal of Psychiatry published a paper citing three case studies in which patients taking Abilify noted an increase in gambling behavior once treatment began. In one case, one patient had a 12 -year history of gambling behavior. After starting Abilify he reported an increase in gambling behavior and “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,” the paper stated. After being switched to a different medication, the patient said he no longer had ongoing thoughts or plans to gamble; this was maintained at the 6-month follow-up. Another patient taking Abilify to treat schizoaffective disorder said gambling became “a reason to live” after taking the medication for 3 months. Prior to treatment, he had been spending about half his money on gambling. Upon taking Abilify, he started spending all of his money. He was changed to a different medication following a recommendation from his psychiatrist; this had a “massive impact” on his gambling. At the 3-month follow-up, after Abilify was stopped, he reported no compulsion to gamble and only played once per week. A third patient had no history of gambling before treatment with Abilify. About one year after being treated with Abilify, he reported “experiencing strong urges to gamble in the form of a euphoric feeling when thinking about gambling. In the following 2 years he incurred debts of around £25 000 on Internet betting sites.” The patient was taken off the medication and had no urge to gamble 1 month later. This abstinence from gambling persisted at both the 3- and 6-month follow-ups.
Pathological gambling was also reported among Abilify patients in a paper published in Addictive Behaviors in 2013. The authors stated that dopamine replacement therapy is one of the risk factors influencing pathological gambling because it may act on the dopamine receptor in the limbic system (D3) and over-stimulate the reward system.
Abilify Tied to Impulse Control Issues
In December 2014, JAMA Internal Medicine published a study showing that dopamine receptor agonist drugs, such as Abilify, are associated with pathological gambling, hypersexuality and compulsive shopping and discussed the drug approval and warnings involving the U.S. Food and Drug Administration (FDA). “Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings,” the authors wrote.
In May 2016, the U.S. Food and Drug Administration (FDA) issued a warning about the antipsychotic drugs, Abilify, Abilify Maintena, and Astrida (generically known as aripiprazole), and impulse control problems. The warning indicated that there have been reports involving individuals being treated with Abilify and compulsive or uncontrollable urges to gamble, shop, binge eat, and have sex. It was also reported that these uncontrollable impulses stopped when the Abilify dose was reduced or the medication was ceased.
Pathological gambling is listed as one of the reported side effects on the aripiprazole drug labels; however, the description does not fully reflect the entire nature of the impulse control risk the agency identified, it wrote. Also, the FDA has become aware of other compulsive behaviors— eating, shopping, and sexual behaviors—that may affect anyone taking Ablify. Because of this, the agency is adding new warnings about all of the excessive behaviors to both the Abilify/aripiprazole drugs’ labels and the patient Medication Guides.
The FDA advises health care professionals to ensure patients and caregivers are aware of the various uncontrollable urges associated with aripiprazole products, such as Abilify. The agency also recommends that health care professionals specifically ask their patients about new or increasing urges they may experience when taking these drugs and that they closely monitor their higher risk impulse control patients for new or increasing uncontrollable urges. High-risk patients include individuals who have a personal history or a family history of obsessive-compulsive disorder (OCD), impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. The FDA suggests health care providers consider reducing or ceasing the Abilify dose should such urges occur.
Meanwhile, each of the impulsive behaviors may have serious side effects to one’s physical, emotional, and financial health. For example, as a result of a gambling compulsion, bankruptcy may occur due to compulsive gambling and lottery playing, which may cause irreparable harm to savings, 401K and other retirement accounts.
Abilify the Focus of Personal Injury Lawsuits
Law360 noted that Abilify has been the subject of a number of personal injury lawsuits, including 20 new federal lawsuits and 12 lawsuits in New Jersey State court. The lawsuits were filed in 2016 by individuals who allege they suffered from uncontrollable urges while taking Abilify.
It is expected that the lawsuits will continue to mount as the popular drug is widely prescribed and patients may not realize that Abilify created or intensified impulse control issues. The federal regulators report that some 7.7 million aripiprazole prescriptions were dispensed in 2015 to some 1.6 million people. The generic version of the drug was approved in April 2015.
In one case, a man alleged that he took Abilify for a decade and developed what was described as a pathological gambling compulsion, losing over $50,000 while on the drug. Of note, the FDA indicated that it has seen 184 reports of compulsive behavior since 2002. Of these, 164 involve gambling, nine involve hypersexuality (compulsive sexual behavior), and four involve compulsive shopping. In some of these cases, the FDA indicated, the individuals had no history of the compulsive behaviors reported until they began taking Abilify.
In one lawsuit brought against Bristol-Myers Squibb, the plaintiff alleged that both European and Canadian regulators added the gambling warnings in 2012 and 2015, respectively.