PROZAC
FLUOXETINE CAPSULES, USP
FLUOXETINE ORAL SOLUTION, USP
FLUOXETINE DELAYED-RELEASE CAPSULES, USP
WARNING
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to
placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young
adults in short-term studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering the use of Prozac or any other antidepressant in a child,
adolescent, or young adult must balance this risk with the clinical need. Short-term studies
did not show an increase in the risk of suicidality with antidepressants compared to
placebo in adults beyond age 24; there was a reduction in risk with antidepressants
compared to placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide. Patients of all ages
who are started on antidepressant therapy should be monitored appropriately and
observed closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation and
communication with the prescriber. Prozac is approved for use in pediatric patients with
MDD and obsessive compulsive disorder (OCD). (See WARNINGS, Clinical Worsening
and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS,
Pediatric Use.)