Tuesday, June 17, 2008
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FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics
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