FDA Approves Prozac for Children, Teens

[Guest guest]

FDA Approves Prozac for Children, Teens

 

 

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.

 

 

 

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.

 

 

 

 

How is it, that this stuff can hit the markets after only 19 weeks

of clinical study? Without even knowing the long term affects?

 

comments anyone?

Misty

http://www..com