TUESDAY, Nov. 20 (HealthDay News) -- 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.
Abilify is co-produced by Otsuka Pharmaceutical Co. of Japan.
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.
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