Paxil - Is It Safe for Children?
NEW ROCHELLE, N.Y., July 29 /PRNewswire/ -- 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Medicines was based on unpublished data from three clinical trials submitted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."
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, Inc., 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.
SOURCE The Medical Letter Inc.
-0- 07/29/2003
/CONTACT: Amanda McLaren of Kovak-Likly Communications, +1-203-762-8833,
for The Medical Letter/
/Web site: medicalletter.org
CO: The Medical Letter Inc.
ST: New York
IN: MTC HEA PUB
SU: NPT CHI
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