Increased Mortality in Elderly Patients with Dementia-Related Psychosis; And Suicidal Thoughts and Behaviors.
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. Brexpiprazole (Rexulti) is not approved for the treatment of patients with dementia-related psychosis [see Increased Mortality in Elderly Patients with Dementia-Related Psychosis under Precautions].
Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of Brexpiprazole (Rexulti) have not been established in pediatric patients [see Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults under Precautions, Use in Children under Precautions].