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Increased mortality risk warning necessary for off-label use of antipsychotics.
The Food & Drug Administration has issued letters to manufacturers of all antipsychotics requiring a new boxed warning of an increased risk of death in elderly patients with dementia. While the atypical antipsychotics have had a similar boxed warning included in their labels since 2005, data showing an increased mortality risk with use of conventional antipsychotics were not available until now. Results from two new observational studies did show an increased risk of death associated with their use. While the agency admits the new studies are not ideal and do possess limitations, the FDA thought the data are strong enough to warrant the label revision nonetheless. Manufacturers of the drugs will have 30 days to submit new language to the FDA for review, or face enforcement action under new authority granted to the agency under FDAAA-the Food and Drug Administration Amendments Act of 2007.