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Prozac, the serotonin-boosting
antidepressant drug, has been approved by the Food and Drug
Administration (FDA) to treat depression in children.
Although the drug,
made by Eli Lilly & Co., was not initially intended for
children, psychiatrists have prescribed it for children in
the past despite a lack of research to prove its effectiveness.
Now, the FDA has
stated that there is proof that Prozac eases depression in
children aged 8 years and older. The drug’s label will
now include child-specific information, which may make doctors,
rather than just depression specialists, more likely to prescribe
it.
Depression affects
close to 2.5 percent of U.S. children and eight percent of
teenagers.
Prozac has also
been approved to treat obsessive-compulsive disorder in children.
The disorder affects about two percent of Americans, and at
least one-third of these cases began during childhood.
While some Prozac
side effects, including tiredness, nervousness, dizziness
and difficulty concentrating, are similar for adults and children,
the drug was found to affect growth in children and teenagers.
Children and teenagers
who took Prozac grew about a half inch less in height and
2 pounds less in weight over a 19-week period than children
who took a placebo. It is not known whether this effect continues
in the long-term; Eli Lilly is further researching these findings.
Reportedly, psychiatrists
favored Prozac’s FDA approval for children. Drug manufacturers
do not have much reason to study the effects of adult drugs
in children, as many times doctors prescribe the medications
without such research.
The FDA has tried
to require more pediatric testing, but the requirement was
recently thrown out by a federal court.
U.S.
Food and Drug Administration (FDA) January 3, 2003
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