A new warning from the FDA addresses the issue of compulsive behaviors associated with Abilify side effects.

In a May 2016 Drug Safety Communication, the agency announced it would require new warnings about compulsive behavior in the labels and Patient Medication Guides for Abilify and all other products using the drug aripiprazole.

Before this new warning was added, the label for Abilify mentioned that some cases of gambling addiction had been reported in conjunction with Abilify treatment.

The FDA now says that warning does not adequately represent all the compulsive behaviors that have been reported in association with Abilify treatment.

The agency collects reports of the negative effects associated with certain drugs in its Adverse Event Reporting System.

Since Abilify was first approved in November 2002, the agency says it has received 184 reports of impulse control problems associated with Abilify.

For scale, the agency notes that about 1.6 million patients got a prescription for Abilify or some other aripiprazole medication from U.S. outpatient retail pharmacies in 2015.

A total of about 7.7 million prescriptions for oral aripirprazole were dispensed that year.

Pathological gambling was by far the most common reported behavioral problem. Other compulsive behaviors reported as possible Abilify side effects have included compulsive shopping, binge eating, and hypersexuality.

The new warning label will address these behaviors, in addition to gambling addiction.

According to the FDA, most of the patients in these reports had no prior history of compulsive behavior. Their reported uncontrollable urges resolved within days or weeks of discontinuing Abilify or reducing their dose.

The agency warns that these compulsive behaviors can affect anyone who takes Abilify or another aripirazole drug.

The announcement adds that other cases of Abilify side effects could have happened that were never reported to the FDA.

Abilify is a brand name that refers to the generic drug aripiprazole. It’s an antipsychotic drug used to treat a few different mental disorders like schizophrenia, bipolar I disorder and major depressive disorder. In some younger patients, it can be used to treat symptoms of Tourette’s disorder and autistic disorder.

According to the FDA, Abilify is different from other atypical antipsychotics in that it only partially blocks the activity of dopamine receptors in the brain.

Abilify has been available on the U.S. market since initial FDA approval in 2002. The same drug is also sold under the brand names Abilify Maintena and Aristada.

Litigation Over Abilify Side Effects

Some patients who experienced compulsive behaviors like those reported to the FDA have launched a series of Abilify lawsuits.

In March 2016, the New Jersey state court system consolidated nine such claims in the Superior Court for Bergen County to coordinate pretrial procedures. Other similar lawsuits have been filed in Florida, Indiana, Minnesota, and New York.

These claims are not the first litigation that manufacturer Bristol-Myers Squibb has faced over Abilify.

In 2007, the company agreed to pay $515 million to resolve allegations by the U.S. Justice Department over the company’s marketing and pricing practices.

Among other allegations, the DOJ had accused the company of illegally promoting  Abilify for “off-label” use in children and geriatric patients.