Abilify Warnings

Increased Mortality in Elderly Patients with Dementia-Related Psychosis and Suicidal Thoughts and Behaviours with Antidepressant Drugs: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Increased Mortality in Elderly Patients with Dementia-Related Psychosis under PRECAUTIONS].
Antidepressants increased the risk of suicidal thoughts and behaviour 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 antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Suicidal Thoughts and Behaviours in Children, Adolescents, and Young Adults under PRECAUTIONS].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviours. Advice families and caregivers of the need for close observation and communication with the prescriber [see Suicidal Thoughts and Behaviours in Children, Adolescents, and Young Adults under PRECAUTIONS].