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U.S. Abilify Warning Label Now Includes Compulsive Gambling

Poker table with FDA Warning text over it

The popular antipsychotic Abilify (aripiprazole) received approval from the U.S. Food and Drug Administration (FDA) in 2002 for the treatment of bipolar disorder, schizophrenia, and other major depressive disorders. Since then, there have been over 180 reported instances of impulse control problems among Abilify users, including compulsive gambling, shopping, binge eating, and hypersexuality.

Even with all of these reported impulse control issues, it took 14 years for the makers of Abilify to warn U.S. consumers about the drug’s link to “pathological gambling and other compulsive behaviors.” In those years where the U.S. Abilify warning label did not cover these issues, lives were destroyed as people with no prior history of compulsive gambling were driven to do so by any means necessary. Some funded their Abilify gambling addiction via credit cards or by borrowing large sums of money. Others were in such dire straits, they reported feeling that they needed to gamble in order to continue living.

A growing number of people from across the country have filed lawsuits against Otsuka Pharmaceutical Company, the makers of Abilify (aripiprazole), alleging the antipsychotic caused them to develop compulsive gambling problems, which resulted in serious financial loss. Former Abilify users claim in their lawsuits that if Otsuka had issued warnings about all of the Abilify side effects, they could have avoided the serious consequences that developed as a result of their compulsive behavior.

Abilify Warning Label Changes in the U.S.

In an effort to address concerns about the link between the drug and compulsive gambling, the makers of Abilify added “pathological gambling” to the language of the ‘Postmarketing Experience’ section on the drug’s U.S. label in January of this year. What the drugmakers did not do at the time, however, was mention gambling in the ‘Warnings and Precautions’ section of the U.S. label or in the patient medication guide, both of which are far more likely to be viewed by consumers.

In May of 2016, the FDA said in a statement that changes would be made to the Abilify warning label to include “compulsive or uncontrollable urges to gamble, binge eat, shop and have sex.” On August 23, 2016, the U.S. Abilify label was updated to include pathological gambling as a main adverse effect in the ‘Warnings and Precautions’ section of the U.S. label.

The Abilify warning label in the U.S. now states that patients can experience “intense urges, particularly for gambling, and the inability to control these urges” while they are taking Abilify. The latest Abilify warning also notes that gambling urges ceased when dosages of the drug were decreased or use was discontinued. Patients may not be able to recognize these behaviors as abnormal, according to the label, so doctors are advised to ask patients or caregivers about gambling urges.

Evidence linking Abilify and compulsive gambling have existed for years. Why did it take Otsuka Pharmaceutical Company and Bristol Myers Squibb Co. so long to change the Abilify warning label in the U.S. to include impulsive behaviors, especially when other countries adopted similar warnings years before?

International Abilify Warning Labels

In 2011, Otsuka issued a ‘Periodic Safety Update Report’ on Abilify to the European Medicines Agency (EMA). This safety update detailed 23 “serious” reports of pathological gambling among patients taking Abilify.

The following year, the EMA issued a report on Abilify, which stated: “post-marketing reports of pathological gambling have been reported among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling.” The report also said individuals who do have a prior history of gambling may be at increased risk and should be monitored.

As a result of the EMA report, Europe required Otsuka to issue a warning on the drug’s label concerning the link between Abilify and compulsive gambling.

In November of last year, Health Canada (Canada’s drug regulatory agency) issued a safety review on Abilify, which detailed 18 instances of patients around the world engaging in compulsive gambling, and six cases of hypersexuality.

According to the report, at least 14 out of the 18 cases of Abilify compulsive gambling were resolved after the patient stopped taking Abilify. Five of the six hypersexuality cases also stopped as well when the patients stopped taking the drug.

As a result of the safety review, Health Canada issued a statement requiring Otsuka to update the Abilify warning label in Canada to include the risk of compulsive gambling, hypersexuality, and other impulsive behaviors.

Abilify Gambling Lawsuit

The law firm of Baum Hedlund Aristei & Goldman is currently representing individuals who have suffered serious financial loss as a result of compulsive gambling behavior brought on by Abilify. Otsuka Pharmaceutical Company and Bristol-Myers Squibb (which helps market Abilify) were obligated to inform consumers about the link between Abilify and impulsive behavior. For over a decade both companies failed in this regard, and as a result, patients who took the drug were unknowingly exposed to serious Abilify side effects.

Our firm is offering free, no-obligation case evaluations to determine if you are eligible to seek compensation by filing an Abilify gambling lawsuit. If you would like to speak with an attorney to learn more about filing an Abilify gambling lawsuit, give us a call at (855) 948-5098.

Baum Hedlund has successfully represented thousands of plaintiffs in wrongful death, personal injury, and class action lawsuits against some of the largest pharmaceutical companies in the world. With decades of experience, our team of attorneys has secured over $1.5 billion in settlements and verdicts on behalf of our clients.

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