FDA is requiring the manufacturers of conventional antipsychotic drugs to add a Boxed Warning and Warning to the drugs’ prescribing information about the risk of mortality in elderly patients treated for dementia-related psychosis similar to the Boxed Warning and Warning added to the prescribing information of the atypical antipsychotic drugs in 2005

Considerations for Healthcare Professionals

• Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.

• Antipsychotic drugs are not approved for the treatment of dementia-related psychosis.  Furthermore, there is no approved drug for the treatment of dementia-related psychosis.  Healthcare professionals should consider other management options.

• Physicians who prescribe antipsychotics to elderly patients with dementia-related psychosis should discuss this risk of increased mortality with their patients, patients’ families, and caregivers.

Source

FDA