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