From http://story.news.yahoo.com/news?tmpl=story&u=/nm/20030103/hl_nm/prozac_teens_dc_1

FDA Approves Prozac for Children, Teens Fri, Jan 03, 2003

NEW YORK (Reuters Health) - The US Food and Drug Administration (news - web sites) said on Friday that it has approved Eli Lilly & Co.'s Prozac (fluoxetine) to treat depression and obsessive compulsive disorder (OCD) in children and adolescents aged seven to 17 years.

...Citing figures from the National Institute of Mental Health, the FDA said depression affects up to 2.5% of children and 8.3% of adolescents in the US. OCD affects roughly 2% of the population and typically begins during adolescence or childhood....

Subject: FDA approves Prozac for children & teens
Organization: Carnegie Mellon University School of Computer Science
From: dst@cs.cmu.edu (Dave Touretzky)
Message-ID: <3e168bd8@news2.lightlink.com>
Date: 4 Jan 2003 02:23:04 -0500

FDA Approves Prozac for Children, Teens Fri Jan 3, 6:03 PM ET

NEW YORK (Reuters Health) - The US Food and Drug Administration said on Friday that it has approved Eli Lilly & Co.'s Prozac (fluoxetine) to treat depression and obsessive compulsive disorder (OCD) in children and adolescents aged seven to 17 years.

According to the FDA, Prozac is the first selective serotonin reuptake inhibitor (SSRI) to receive approval for treating depression in children. The approval was based on two studies of children and adolescents with depression, which showed that the drug produced a statistically significant effect compared with placebo. The drug also produced a statistically significant effect compared with placebo in studies of children and adolescents with OCD.

Side effects associated with Prozac use among children and adolescents were similar to those observed in adults and included nausea, tiredness, nervousness, dizziness and difficulty concentrating.

The FDA noted that in one of the clinical studies, after 19 weeks of treatment with Prozac, children gained, on average, about 1.1 cm less in height (about a half an inch) and about one kilogram less in weight (about two pounds) compared with children treated with a placebo. According to the agency, "the clinical significance of this observation on long-term growth is unknown."

Lilly will conduct a phase IV post-marketing study to further evaluate the potential impact of Prozac on long-term growth in children.

Citing figures from the National Institute of Mental Health, the FDA said depression affects up to 2.5% of children and 8.3% of adolescents in the US. OCD affects roughly 2% of the population and typically begins during adolescence or childhood.

Indianapolis-based Lilly lost patent protection on Prozac in August 2001. The drug was once a blockbuster, pulling in sales of $2.5 billion in 2000. Since losing patent protection, several generic formulations of Prozac have flooded the US market, cutting sharply into Lilly's revenues.

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