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Paxil - Is It Safe for Children?

Jul 29, 2003 | PR Newswire

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Letter on Drugs and Therapeutics," the recommendation made by the UK's Committee on Safety of Medicines was based on unpublished data from three clinical trials submitted to the FDA by GlaxoSmithKline to gain approval for use of paroxetine to treat obsessive-compulsive disorder in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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