Abilify Lawsuits to be Organized in Florida

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Abilify (aripiprazole) lawsuits pending nationwide will be centralized in a multidistrict litigation (MDL) in Florida. The plaintiffs and defendants—Otsuka Pharmaceuticals and Bristol-Myers Squibb—have agreed to the move.

A total of 22 lawsuits from 12 jurisdictions are scheduled for centralization in the Northern District of Florida; another 22 actions remain pending nationwide, according to the Judicial Panel on Multidistrict Litigation (JPML), The Ring of Fire (trofire.com) reported. All, or some, of these 22 cases may be added to the MDL. Two additional cases were withdrawn by plaintiffs and two other cases were remanded back to their original jurisdictions. The Honorable Margaret C. Rodgers will preside over the MDL.

The lawsuits similarly allege that Abilify may cause compulsive behaviors in patients, including gambling, that they question if Otsuka Pharmaceuticals and Bristol-Myers Squibb were fully aware of the seriousness of those side effects, and that they question if the warnings were adequate, according to trofire.com. MDLs help improve efficiency and minimize redundancy, time, and use of judicial resources, trofire.com pointed out.

Abilify is prescribed for the treatment of schizophrenia, bipolar disorder, and major depressive disorder (MDD). Abilify is also known to be prescribed off-label, or for treatments not approved by the U.S. Food and Drug Administration (FDA), for aggressive behavior, irritable mood, mood swings, and other behavioral issues.

Mild to moderate Abilify side effects include anxiety, dizziness, headache, insomnia, and nausea. Patients also report significant, life changing, and shocking adverse reactions, including side effects that have led to relationship strains and severe economic losses and may include behaviors that to feeling induced to become involved in activities tied to receiving pleasure or gratification. Gambling addiction is the most common serious compulsive side effect; however, sexually compulsive behaviors, compulsive shopping, and compulsive binge eating have been reported, as well.

The FDA updated the warning label on Abilify, Abilify Maintena, Aristada, and generic aripiprazole to include information concerning compulsive behavior. According to the agency’s Safety Announcement, there have been reports of uncontrollable urges to gamble, binge eat, shop, and have sex in patients who take these drugs. The FDA announcement indicated that the compulsive behaviors typically ceased once the Abilify dosage was lowered or the drug was discontinued.

The current label included pathological gambling as a reported side effect; however, the FDA indicated that this was not an accurate description of impulse-control problems identified. The label also did not include information about other compulsive behaviors. Because of this, the agency indicated that it is updating the warning label.

The FDA approved Abilify, the first aripiprazole drug, in November 2002. Since, nearly 200 cases of impulse-control problems were submitted to the agency’s Adverse Event Reporting Systems (FAERS). There may be additional cases that the FDA is not aware of, it noted. In an agency letter, it cited Abilify promotional material that were “false or misleading because it makes misleading claims and presentations about the drug” and were “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.”