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Rand Questions Off-label Use

There is insufficient evidence that atypical antipsychotics are effective in treating eating disorders, substance abuse, and insomnia — medical conditions that these drugs were not approved to treat — according to a new Rand study.

Other off-label conditions do respond, though. Evidence supports the effectiveness of some atypical antipsychotics in reducing symptoms of generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, and behavioral symptoms in elderly patients with dementia, although significant side effects were noted.

“The use of atypical antipsychotic medications has spread rapidly beyond the illnesses they ... were developed to treat,” says lead author Alicia Ruelaz Maher, MD, a psychiatrist and researcher at Rand. “While evidence suggests the drugs help reduce symptoms for some off-label illnesses, we found a lack of evidence for others.”

The findings are published in the September edition of the Journal of the American Medical Association.

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