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. Lumateperone is not approved for the treatment of patients with dementia-related psychosis. (5.1)
• Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of lumateperone have not been established in pediatric patients.