Abilify® (aripiprazole) is an atypical anti-psychotic drug developed and manufactured by Otsuka Pharmaceutical Company in the 1980s. In the United States, the drug has been sold, marketed and promoted by Bristol-Myers Squibb Company under an agreement between the two entities. Abilify® was approved for sale on the United States in 2002 for treatment of schizophrenia, but its approved uses were expanded to include bi-polar disease, major depressive disorder, irritability associated with autistic disorder, and Tourette’s disorder.
Both Bristol-Myers Squibb and Otsuka aggressively promoted Abilify®, including illegal promotion for off-label uses such as pediatric use and to treat dementia-related psychosis. In 2005 Bristol-Myers Squibb paid a $515 million penalty to the United States government to settle allegations that the company had aggressively marketed Abilify® to geriatric patients as well as children and adolescents for unapproved off-label purposes. In 2016, Bristol-Myers Squibb paid $19.5 millions to various state governments to settle allegations that the company had minimized the risks for Abilify®, misrepresented data from clinical studies and illegally promoted the drug off label on purpose. The company also paid $30 million to the state of California for illegally paying doctors to prescribe its medications, including Abilify®.
Compulsive Gambling: Dangerous Side Effect of Abilify®
Compulsive and pathological gambling have been long recognized as a psychiatric disorder by the American Psychiatric Association. According to the current edition of the APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM-V), pathological gambling is classified as “gambling disorder” under the category Substance-Related and Addictive Disorders. Such classification recognizes that gambling behaviors activate or are activated by reward systems similar to those activated by drugs of abuse, and produce some behavioral symptoms comparable to those produced by substance abuse disorders.
Connection Between Abilify® and Compulsive Behavior
Abilify® is a partial and full dopamine agonist. Dopamine is a chemical that plays a key role in controlling the brain’s reward and pleasure centers, and dopamine’s role in compulsive behavior and pathological gambling is well- known. Dopaminergic reward pathways have frequently been implicated in the etiology of addictive behavior, and researchers have identified dopamine as a potential cause of pathological gambling for years.
Abilify® Warnings in the Unites States
Despite warnings and advisories in Europe and Canada—for the same drug sold to patients in the United States—up until January 2016, none of the labeling or promotional materials for Abilify® in the United States mentioned that pathological gambling has been reported in patients prescribed Abilify®. Indeed, neither the labeling nor the promotional materials for Abilify® in the United States contained any mention of the word “gambling” or “compulsive behavior.” In January 2016, pathological gambling was added, but only to the Post-Marketing Experience section of the label and not to the more prominent Warnings and Adverse Reactions section. Moreover, the manufacturer failed to make any mention of gambling in its Patient Medication Guide, a source of information likely viewed by physicians and patients.
A few months later, on May 3, 2016, the FDA released a warning that Abilify® was associated with “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” and directed aripiprazole manufactures to add new warnings to both the drug labels and the Patient Medication Guides. The FDA noted that although the impulse control problems are rare, they may result in real harm to the patient if not recognized, and recommended that doctors “make patients and caregivers aware of the risk of these uncontrollable urges,” “closely monitor” patients, and consider reducing or stopping Abilify if compulsivity emerges.
At the present time, the warning on the package label reads as follows:
In the Warnings and Precautions Section:
Pathological Gambling and Other Compulsive Behaviors: Consider Dose Reduction or Discontinuation.
In the section on post-marketing events:
Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.
Since the warning was added, the scientific literature regarding the connection between aripiprazole and impulse control behaviors including compulsive gambling has only gotten stronger, and suggests that it is not nearly as rare as the FDA warning may have implied. Thankfully, for most people, cessation of the drug has also led to cessation of the offending behavior. However, because doctors and patients weren’t warned to look for the signs of drug-induced compulsive gambling, they may not have learned about the connection until patients had depleted their savings, lost their homes or their jobs, damaged their reputations, and more. And all of this having been unnecessary, had the manufacturer simply warned doctors and patients to be on the lookout for unusual behavior.
Legal Team of Dangerous Drug Lawyers at Williams Cedar Pursue Claims for Those Harmed by Abilify®
Many consumers who have been prescribed and taken Abilify have pursued legal action against Otsuka and Bristol-Myers. At Williams Cedar, our dangerous drug lawyers have extensive experience pursuing compensation for those harmed by dangerous or defective drugs. We are a dedicated team of trial lawyers fighting to protect consumers nationwide.
If you believe that you or a loved one has experienced a gambling problem or other compulsive behaviors as a result of taking Abilify®, call us today at 215-557-0099 or submit an online inquiry. We will contact you to let you know if you quality for an individual Abilify lawsuit or class action. Do not delay — statutes of limitations may apply.