The U.S. Food and Drug Administration has approved Abilify (aripiprazole) as an add-on therapy for people with major depressive disorder who don't benefit enough from antidepressant therapy alone, its makers said Tuesday.
Abilify, approved in November 2002 to treat schizophrenia, is among a class of medications called atypical antipsychotics. The latest approval followed clinical studies involving 743 patients.
Elderly people with dementia-related psychosis who are treated with atypical antipsychotics are at greater risk of death, drug maker Bristol-Myers Squibb warned in a statement.
Side effects of Abilify may include akathisia -- a syndrome characterized by feelings of inner restlessness and the urge to move. Other "adverse events" reported among clinical users included insomnia, constipation, fatigue, and blurred vision, the companies said.
Learn more about this drug from the FDA