HHS AGENCY FINDS LITTLE EVIDENCE TO SUPPORT OFF-LABEL ANTIPSYCHOTIC USE

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. 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.

AHRQ acknowledged that risperidone and quetiapine can help some patients with obsessive-compulsive disorder when used with antidepressants. In addition, risperidone and olanzapine improve sleep problems and depression in men with combat-related post-traumatic stress disorder when used with antidepressants or other psychotropic medications, the agency said.

A 2001 AHRQ-funded study found that about 21 percent of all prescription drug use was for conditions not included on the labels. The latest report urged more research into new treatments for dementia patients with severe agitation to create alternatives to off-label use.

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