"Off-label" Use of Antipsychotic Drugs for Some Conditions Not Supported by Evidence

Press Release Date: September 27, 2011

There is little evidence to support the use of atypical antipsychotic drugs for some treatments other than their officially approved purposes, even though many clinicians continue to commonly prescribe these drugs for so-called "off label" uses, according to a new report from the U.S. Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ). An article based on information in the report will be published in the September 28 issue of the Journal of the American Medical Association.

The report finds that atypical antipsychotic medications—approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia, bipolar disorder and, in some cases, depression—are commonly prescribed to treat other behavioral conditions.

The report, which is an update of a 2007 report, found some evidence to support the off-label use of atypical antipsychotic medications. Evidence was strongest, for example, for the off-label use of risperidone, olanzapine and aripiprazole to treat symptoms of dementia; quetiapine to treat generalized anxiety disorder; and risperidone to treat obsessive-compulsive disorder.

However, evidence was lacking to justify the use of these and other atypical antipsychotic drugs to treat substance abuse problems, eating disorders or insomnia, the report noted. Atypical antipsychotic medications have been linked to some harms, including a small increased risk of death in elderly patients with dementia, according to the report.

The report, a comparative effectiveness review prepared for AHRQ's Effective Health Care Program by the Southern California Evidence-based Practice Center, based at the RAND Corporation, is available at http://www.effectivehealthcare.ahrq.gov.

"While atypical antipsychotic medications are not for everyone, many patients who suffer from psychiatric conditions have found these drugs to be very helpful," said AHRQ Director Carolyn M. Clancy, M.D. "However, their off-label use, while in some cases beneficial, is of concern because we just don't know enough about their effectiveness and safety for multiple behavioral conditions. This report will give clinicians and patients additional information they can use to make the best possible decisions."

Antipsychotic drugs are commonly divided into two classes, reflecting two waves of development: conventional (or "first generation") and atypical (or "second generation"). Currently, nine atypical antipsychotic drugs have been approved by the FDA: aripiprazole, asenapine, clozapine, iloperidone, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone.

The report's authors also cautioned against assuming that all atypical antipsychotic drugs are similar, because they vary in effectiveness and side effects.

The report, Off-Label Use of Atypical Antipsychotics: An Update, is the latest comparative effectiveness review from AHRQ's Effective Health Care Program. The Effective Health Care Program helps patients, doctors, nurses, pharmacists and others choose the most effective treatments by sponsoring the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. More information about the program can be found at http://www.effectivehealthcare.ahrq.gov.

For more information, please contact AHRQ Public Affairs: (301) 427-1892 or (301) 427-1998.

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Current as of September 2011
Internet Citation: "Off-label" Use of Antipsychotic Drugs for Some Conditions Not Supported by Evidence. September 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/newsroom/press-releases/2011/ehcofflabel.html