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Paxil pregnancy warning strengthened again.(News)
The Food and Drug Administration has stepped up warnings that paroxetine increases the risk of congenital defects, especially cardiovascular malformations.
In September, GlaxoSmithKline, which markets paroxetine under the trade name Paxil, had updated the drug's labeling in conjunction with the FDA. The change was based on initial data from a U.S. insurance claims database indicating a slightly higher risk of fetal defects in women who had taken the drug in the first trimester.
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When further information became available in December, GlaxoSmithKline and the FDA agreed that ...
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