A new study found that the antidepressant effects of Abilify (aripiprazole) are so minimal that its risks significantly outweigh the alleged benefits. The medication manufactured by Bristol-Myers Squibb is one of the most controversial ones actually sold in the U.S. market. According to the many Abilify lawsuits filed in many state and federal courts across the country, the prescription antipsychotic may be associated with severe side effects which may seriously damage a patient’s life.

Aripiprazole is, in fact, linked with a hidden risk of developing uncontrollable impulses which may lead to self-destructive behaviors such as sex addiction and compulsive gambling. Since the first litigation was filed in court on January 2016, the Abilify litigation kept growing, until in June 2016 the Judicial Panel on Multidistrict Litigation (JPML) centralized them in the Northern District of Florida (MDL No. 2734). Today, more than pending 350 cases are being overseen by Chief District Judge Casey M. Rodgers.

Plaintiffs kept accusing the drugmaker of concealing critical evidence from the public about the potential dangers of the antipsychotic. According to their claims, Bristol-Myers Squibb and Otsuka Pharmaceuticals failed to warn patients and doctors of this serious risk of compulsive behaviors, and willfully downplayed the side effects of Abilify.

The manufacturers always defended themselves by arguing that the benefits of their medication outweigh its risks. They cited many self-funded clinical trials, though, since no independent study ever proved their positions, so far. A recent study published in the Journal of the American Medical Association, however, seemingly put them in a difficult position, since it suggests that Abilify’s benefit/risk ratio is quite unfavorable, at least in depressed patients.

A group of researchers followed up a randomized clinical trial carried on more than 1500 patients from 2012 to 2015. These subjects were mostly middle-aged men suffering from major depressive disorder (MDD) who were unresponsive to at least one course of treatment. Subjects within the study thus switched from their original medication or augmented their treatment by receiving a second one. The study compared the safety and effectiveness of either Wellbutrin/Zyban (bupropion) or Abilify (aripiprazole), to check which alternative worked better.

According to their findings, aripiprazole seems to be somewhat effective at treating depression, but not so much. The likelihood of remission was in fact defined as “modestly increased,” and came at the price of frequent and significant side effects. Many patients experienced substantial weight gain, excessive sleepiness and mental agitation. The researchers ultimately expressed their doubts on whether Abilify can be used as an antidepressant, since its risks seem to outweigh the relatively minor benefits. They even concluded that “further analysis including cost-effectiveness is needed to understand the net utility of this approach.”

Article by Dr. Claudio Butticè, Pharm.D.