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Compulsive Behaviors Warning Added to Abilify Labeling

FDA has required new warnings to be added to the labeling of Abilify regarding increased risks of engaging in uncontrollable compulsive behavior including shopping, gambling, eating, and having sex.

The U.S. Food & Drug Administration (FDA) is requiring new warnings to be added to the labels of aripiprazole products (Abilify, Abilify Maintena, Aristada) regarding an increased urge to gamble, binge eat, shop and have sex.

Free Confidential Lawsuit Evaluation: If you or a loved one experienced compulsive behaviors after taking Abilify, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the Problem?

May 3, 2016 – According to the FDA, although the impulse-control problems associated with aripiprazole are rare, they may result in harm to the patient or others if they go unrecognized. The uncontrollable urges stop once the drugs are discontinued or the dosage is reduced, the agency said.

Since Abilify was first approved in Nov. 2002, FDA has identified at least 167 cases linking aripiprazole use to impulse-control problems in adults and children. Pathological gambling was the most prevalent (164 cases), but compulsive eating, spending and sexual behaviors were also associated with the medication.

Because the FDA’s Adverse Event Reporting System (FAERS) only includes reports submitted to the agency, it is likely that there are many more cases of compulsive behavior in Abilify users that were never reported. In 2015 alone, about 1.6 million aripiprazole prescriptions were filled in the U.S.

Pathological gambling was added to aripiprazole’s labeling in Jan. 2016, but this description doesn’t accurately reflect the nature of impulse-control risk that the FDA has identified, and it doesn’t detail the other compulsive behaviors such as compulsive eating, shopping and sexual actions.

According to the FDA, healthcare providers should know that these problems may occur in any patient, regardless of whether or not they have a history of compulsive behavior. Although the side effects were reported to stop once the medication was discontinued or the dose was reduced, patients should be advised never to quit aripiprazole treatment without talking to their doctor first.

Do I Have an Abilify Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Abilify lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by Abilify side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

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