Increased Risk of Death in Elderly Patients Taking Drugs for Dementia

FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldol (haloperidol) and Prolixin (fluphenazine). A similar warning was added to "atypical" antipsychotic drugs in 2005. Atypicals include such drugs as Zyprexa (olanzapine), Seroquel (quetiapine) and Risperdal (risperidone).

Both conventional and atypical antipsychotics are approved to treat schizophrenia, but neither type is approved for dementia-related psychosis. FDA is reminding physicians that antipsychotic drugs are not indicated for this condition, and that elderly patients treated with antipsychotics are at increased risk of death.

At this time there is no approved drug to treat dementia-related psychosis, and FDA advises healthcare professionals to consider other options to manage these patients. Physicians who prescribe antipsychotics for elderly patients with dementia-related psychosis should discuss the increased risk of death with the patient, the patient's family, and caregivers.

Additional Information:

FDA MedWatch Safety Alert. Antipsychotics, Conventional and Atypical. June 16, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics