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Study Questions 'Off-Label' Use of Antipsychotics


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Using the drugs "off label' for conditions other than their original approval is perfectly legal but causes concern among some experts. A 2001 report by the AHRQ concluded that about 21 percent of prescribed drug use was for conditions not indicated on the label.

Atypical antipsychotics have also been studied for treating Tourette syndrome and autism in children.

"Off-label use isn't necessarily bad," Atkins said. "To say it's not an approved indication doesn't mean there's no evidence."

Text Continues Below



But after reviewing 84 published studies on atypical antipsychotics, the authors of the new study concluded there can be problems. Not only is quality evidence lacking to support off-label use of the drugs, there is evidence of severe side effects, including weight gain, tremors and stroke.

"These drugs have a lot of side effects," Licinio confirmed. "They also tend to be very expensive."

Although some patients can benefit from the off-label use, many can be treated with a different drug without the side effects, he added.

The drugs are also used widely in children for off-label purposes, said Dr. Cheryl Corcoran, assistant professor of psychiatry at Columbia University and a researcher in schizophrenia at the New York State Psychiatric Institute in New York City.

"There are very few clinical trials in children, but there's enough information from other sources to show that these medications can be very problematic for children, with side effects such as weight gain, insulin resistance and changes in cholesterol," she said.

Licinio added there are few studies that looked at the drugs in "real-world" settings, which often means in combination with other drugs. "It's not only that people are getting anti-psychotics, they are being added to what they are already taking," he said. "They are being added, and they have not been tested in combinations, and I think it's a problem."

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 1/19/2007

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SOURCES: David Atkins, M.D., chief medical officer, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, Md.; Julio Licinio, M.D., chairman, department of psychiatry and behavioral sciences, University of Miami Miller School of Medicine; Cheryl Corcoran, M.D., assistant professor of psychiatry, Columbia University, and researcher in schizophrenia, New York State Psychiatric Institute, New York City; Jan. 17, 2007, Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics, Agency for Healthcare Research and Quality


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