Conventional antipsychotics get boxed warning
The FDA is requiring a boxed warning be added to conventional antipsychotics to explain an increased risk of death in elderly patients treated for dementia-related psychosis. This decision is a follow-up to a similar labeling change made in 2005 for atypical antipsychotic drugs. Both conventional and atypical antipsychotics are approved for the treatment of symptoms associated with schizophrenia; neither is approved for use to treat dementia-related symptoms.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110212.htm.