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NEW
ROCHELLE, NY — July 29, 2003
The UK's Committee on Safety of Medicines recently issued a "Dear
Colleague" letter advising physicians not to use paroxetine
(Paxil), a selective serotonin reuptake inhibitor (SSRI),
to treat children and adolescents with depression. The FDA has recently
followed suit. Should physicians stop prescribing paroxetine and
perhaps other SSRIs in children and adolescents? According to The
Medical Letter on Drugs and Therapeutics, the recommendation
made by the UK's Committee on Safety of Medicines was based on unpublished
data from three clinical trials submitted to the FDA by GlaxoSmithKline
to gain approval for use of paroxetine to treat obsessive-compulsive
disorder in children. The data indicated that "emotional liability",
a category of reactions that included various other symptoms in
addition to thoughts of suicide and attempted suicide, occurred
in 3.2% of children with paroxetine and 1.5% with placebo.
Adverse
effects of SSRIs, which include nausea, nervousness, insomnia and
fatigue, are similar in children and adults. All antidepressants
can cause mania in adults or children with underlying bipolar disorder.
"There
are no convincing data showing that SSRIs, including paroxetine,
are any less safe in children than in adults," said Gianna
Zuccotti, Deputy Editor of The Medical Letter. "We feel
that these drugs are much more likely to prevent suicide than to
cause it."
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About
The Medical Letter
The Medical Letter Inc., a nonprofit organization founded in 1958,
offers health care professionals objective, independent analyses
of both prescription and over-the-counter drugs. In addition to
its newsletters, The Medical Letter on Drugs and Therapeutics
and Treatment Guidelines from The Medical Letter, it also
publishes handbooks and software on topics such as adverse drug
interactions and antimicrobial therapy. The Medical Letter is supported
entirely by subscriber fees and is based in New Rochelle, NY. For
more information about The Medical Letter call (800) 211-2769 or
visit their Web site at www.medicalletter.org.
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