Schizophrenia :: Evidence Lacking to Support Many Off-label Uses of Atypical Antipsychotics

Some newer antipsychotic medications approved to treat schizophrenia and bipolar disorder are being prescribed to millions of Americans for depression, dementia, and other psychiatric disorders without strong evidence that such off-label uses are effective, according to a new analysis by the Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ).

The federally funded comparative effectiveness review of these drugs?called atypical antipsychotics?identified the medications’ potential for serious side effects while pointing to an “urgent need” for more research into new treatments for the growing population of dementia patients who display severe agitation.

“This report emphasizes the importance of understanding the risks and benefits of different medicines,” said AHRQ Director Carolyn M. Clancy, M.D. “Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good.”

Atypical antipsychotics are second-generation medicines designed to cause fewer neurological complications than conventional antipsychotics. They include aripiprazole (sold as Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon). Each is approved by the Food and Drug Administration to treat schizophrenia and bipolar disorder, and risperidone is also approved to treat irritability in children ages 5 to 16 who have autism.

Some studies suggest that atypical antipsychotics may help patients with mental health conditions for which there are no Food and Drug Administration (FDA) approved alternatives. Risperidone and quetiapine, for example, help certain patients with obsessive-compulsive disorder when used in conjunction with antidepressants. Risperidone and olanzapine improve sleep problems, depression, and other symptoms in men with combat-related post-traumatic stress disorder when used to augment therapy with antidepressants or other psychotropic medications.


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