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U.S. STUDY FINDINGS DON'T SUPPORT OFF-LABEL ANTIPSYCHOTIC USE

January 19, 2007

An analysis of 84 studies by HHS' Agency for Healthcare Research and Quality (AHRQ) found no strong evidence that atypical antipsychotics are effective for many of the off-label uses for which they are commonly prescribed.

Medications approved to treat schizophrenia and bipolar disorder are being prescribed to millions of Americans to treat other mental health conditions, some of which lack FDA-approved alternatives, AHRQ said Jan. 17. However, studies supporting the off-label uses of these drugs were either too small or not scientifically rigorous enough to be valid, the researchers said.

The agency looked at studies regarding the use of atypical antipsychotics such as aripiprazole, olanzapine, quetiapine, risperidone and ziprasidone in treating disorders including dementia, depression and obsessive-compulsive disorder. The medications are second-generation antipsychotics designed to cause fewer neurological complications than older antipsychotics.

Even if the studies were valid, the increased risk of adverse events cancels out any potential benefits of using the atypical antipsychotics, the report said. Side effects of the newer antipsychotics include stroke, tremors, significant weight gain, sedation and gastrointestinal problems, according to the report.

The report can be seen at effectivehealthcare.ahrq.gov/synthesize/reports/final.cfm?Document=14&Topic=34.