LATUDA® (lurasidone HCI)
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an
increased risk of death. LATUDA is not approved for use in patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents, and young adults in short-term
studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and
communication with the prescriber. LATUDA is not approved for use in patients under the age of 18 years.