Jane S. Ricciuti, RPh, MS


February 19, 2003

In This Article


(fluoxetine HCl) Capsules

Manufacturer: Lilly

Drug Approval Classification: Supplemental NDA (approval date: 1/03/03)

New Indication: Prozac (fluoxetine) is now indicated for the treatment of children and adolescents 7 to 17 years of age who have depression (major depressive disorder) or obsessive-compulsive disorder (OCD).

Clinical Summary: Pediatric clinical studies evaluated fluoxetine in children and adolescents in 2 placebo-controlled clinical trials in depressed outpatients whose diagnoses corresponded to standard rating criteria (under the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders).

Adverse Effects: No new adverse events occurred in pediatric patients compared with known adult adverse events. The most common side effects included nausea, tiredness, nervousness, dizziness, and difficulty concentrating.

In a 19-week clinical trial of children and adolescents aged 8 to 17 years, pediatric patients treated with fluoxetine grew, on average, about 1.1 cm (about half an inch) less in height and gained about 1 kg (about 2 pounds) less in weight than pediatric patients treated with placebo. The clinical significance of this observation with regard to long-term growth is unknown. Lilly has agreed to conduct a phase 4 postmarketing study to further evaluate any potential impact of fluoxetine on long-term growth in children.

Prozac (fluoxetine HCl) Capsules Letter

Prozac (fluoxetine HCl) Capsules


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