AntidepressantsProzac (fluoxetine HCl) Capsules
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.
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: February 2003 - Medscape - Feb 20, 2003.