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According to a new study that examined the best approaches for treating depression among individuals who do not respond to antidepressants, there were few benefits in using Abilify, an antipsychotic medication that is widely used to treat depressive disorders.
Researchers with Veterans Affairs looked at the effectiveness of the common practice of prescribing Abilify for depression. In a report published in the Journal of the American Medical Association (JAMA) on July 11, findings indicate that the Abilify benefits for depression were statistically significant, but minor, and came with more adverse side effects.
Abilify (ariprazole) is one of the top-selling brand name medications on the market in the United States, generating sales in excess of $6 billion per year. It was introduced in 2002 for treatment of schizophrenia, bipolar disorder and other major depressive disorders, but is also widely used to treat irritability, aggression, mood swings and other behavior issues.
Researchers conducted a randomized clinical trial of 1,522 patients, 85% of whom were men, who suffered major depressive order who had not responded to antidepressants. They have some of the men Abilify, and gave some of them burpropion, an antidepressant that includes the brand name drugs Wellbutrin and Zyban.
When the researchers compared Abilify to antidepressants already shown to be ineffective, they found that 29% of patients achieved remission, compared to 22% of the patients who achieved remission when they tried antidepressant treatment again.
In addition, researchers found that the side effects of Abilify caused more frequent reports of adverse effects, including sleepiness, a restless movement disorder known as akathisia, and weight gain.
“Among a predominantly male population with major depressive disorder unresponsive to antidepressant treatment, augmentation with aripiprazole resulted in a statistically significant but only modestly increased likelihood of remission during 12 weeks of treatment compared with switching to bupropion monotherapy,” the researchers concluded. “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.”
The findings come as a growing number of Abilify lawsuits continue to be filed against the manufacturer of the drug, alleging that inadequate warnings about the potential risks were provided to users and the medical community. Among common problems linked to the medication are compulsive behaviors, such as gambling addictions and other destructive behaviors.
The litigation emerged after the FDA required new warning information about the link between Abilify and impulse control problems in May 2016, urging doctors, patients and caregivers to be on the lookout for symptoms of uncontrollable urges to gamble, binge eat, shop or engage in reckless sexual activity while using the medication.
Although information about the risk of Abilify impulse control disorders was added to the label in Europe as early as 2012, plaintiffs allege that the important information was withheld in the United States, causing users to suffer severe gambling losses and damage to their financial stability or family relationships due to the failure to warn.
Since October 2016, cases filed against Bristol-Myers Squibb and Otsuka Pharmaceuticals throughout the federal court system have been consolidated as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Casey Rodgers in the Northern District of Florida for coordinated discovery and pretrial proceedings.