U.S. health regulators have issued a new alert regarding the potential for Abilify to cause compulsive gambling and other impulse control issues. The drug’s label, along with the labels for Abilify Maintena and Aristada, will be modified with stronger warnings about these potential side effects.
According to the U.S. Food & Drug Administration (FDA), Abilify (aripiprazole) is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s syndrome, and irritability associated with autism. It may also be used in combination with antidepressants to treat depression.
In an alert issued on May 3rd, the FDA noted that the label for Abilify and other aripiprazole products already included mention of pathological gambling as a possible side effect. However, the agency said it has become aware of other impulsive behaviors associated with the drug, including compulsive eating, shopping, and sexual actions, and has concluded that the current labeling does not entirely reflect the nature of the impulse-control risk
A recent review of the FDA’s adverse event database and the medical literature published since Abilify was approved in 2002 revealed a total of 184 case reports in which there was an association between aripiprazole use and impulse-control problems. There were 167 U.S. cases, which included adults and children. The vast majority – 164 – involved compulsive gambling, while the remaining included compulsive eating, spending or shopping, and sexual behaviors.
The majority of reports involved patients with no prior history of impulse control issues. The uncontrollable urges stopped shortly after patients ceased treatment with aripiprazole, or had the dosage reduced.
Several Abilify lawsuits have already been filed in U.S. courts on behalf of patients who allegedly developed a gambling addiction due to their use of the medication. All of the complaints accuse the drug’s manufacturer of failing to provide adequate warnings regarding the impulsivity risks associated with Abilify. The lawsuits note that while such information was provided to consumers and medical professionals in Canada and Europe, a mention of “pathological gambling” was only added only to the Postmarketing Experience section of the U.S. label this past January. What’s more, the drug’s manufacturers did not update the Abilify patient medication guide at that time, even though the lawsuits contend that the guide is more likely to be viewed by doctors and patients.