Sucidal Thoughts and Behaviors; Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Suicidal Thoughts and Behaviors

• Antidepressants increased the risk of suicidal thoughts and behavior 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 emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. SYMBYAX is not approved for use in children less than 10 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Patient Counseling Information (17.2)].

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SYMBYAX (olanzapine and fluoxetine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.2)].