Resources for Food and Drug Administration (FDA)

FDA Alert Outlines Risk of Conventional Antipsychotic Use in Older Patients

www.aafp.org

In an alert issued June 16, the FDA notified physicians that the agency has directed manufacturers of conventional antipsychotic drugs to add specific warnings about the risk of mortality in elderly patients being treated for dementia-related psychosis to the drugs' package labels. The required warnings would be similar to those added to the prescribing information of atypical antipsychotic drugs in 2005. FDA officials based this week's action on an analysis of findings from two observational epidemiological studies that examined the risk of death in older Canadian patients who were treated with conventional antipsychotic drugs.

View the Resource

Share or bookmarklet this web page at: