WARNINGS: INCREASED MORTALITY ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

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 behaviour with antidepressants use in patients over age 24; there was a reduction in risk with antidepressants use in patients aged 65 and older. [see Warnings and Precautions (5.3)].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behavior. Advise families and caregivers of the need for close observation and communication with the prescriber. [see Warnings and Precautions (5.3)]

1.Maintenance Treatment of Bipolar I Disorder

ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as

monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was

demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trials in adults. [see Clinical Studies (14.2)].Adjunctive Treatment of Major Depressive Disorder

ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode. [see Clinical Studies (14.3)].

1.4

ABILIFY is indicated for the treatment of irritability associated with autistic disorder.

Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years)

with irritability associated with autistic disorder (including symptoms of aggression

towards others, deliberate self-injuriousness, temper tantrums, and quickly changing

moods) [see Clinical Studies (14.4)].

Tourette's Disorder

ABILIFY is indicated for the treatment of Tourette's disorder. Efficacy was established in

one 10-week placebo-controlled trials in pediatric patients (6 to 18 years) with Tourette's

disorder.

Special Considerations in Treating Pediatric Schizophrenia

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