n a report published by the Journal of the American Medical Association (JAMA), researchers at the Veterans Affairs found that the benefits of the antidepressant add-on drug Abilify were minor.
Meanwhile, the FDA has received 164 reports of pathological gambling caused by Abilify from November 2002 through January 2016.
Since October 2016, 234 mass tort lawsuits have been consolidated before Chief US District Judge M. Casey Rodgers in the Northern District of Florida, in MDL 2734, IN RE: Abilify (Aripiprazole) Products Liability Litigation. They charge that Bristol-Myers Squibb and Otsuka Pharmaceuticals Bristol-Myers Squibb knew about the side effect but failed to warn consumers, downplaying risks to protect billions in sales.
The researchers questioned the use of Abilify for depression: "Given the small effect size and adverse effects associated with aripiprazole, further analysis including cost-effectiveness is needed to understand the net utility of this approach.”
In a 12-week follow-up of a randomized clinical trial of 1,522 patients with major depressive disorder (85% men) unresponsive to previous antidepressant treatment, only 29% achieved remission after adding Abilify with their antidepressant.
It was not until the FDA ordered stronger labels in May 2016 that American patients and doctors were finally warned about uncontrollable urges to gamble, eat, shop, or have sex.
Europe required BMS and Otsuka to add a warning label about “pathological gambling” from Abilify in November 2012, as well as recommending caution in patients with a history of gambling addiction.
Abilify is one of the top-selling medications in the U.S., with sales of more than $6 billion per year. It is an antipsychotic drug that the FDA approved in 2002 for schizophrenia, bipolar disorder, and major depressive disorders. Today, Abilify is widely used “off-label” to treat irritability, aggression, and mood swings.
