Paxil Gets Stronger Warning

December 2005

After months of alerting doctors about Paxil’s risk to pregnant women, the Food and Drug Administration (FDA) is making it official.

The FDA requested GlaxoSmithKline classify the antidepressant drug as “Category D.” This classification means that studies show that there is an elevated risk to the unborn child in pregnant women. Two studies of expectant mothers taking Paxil during the first trimester indicated their babies were twice as likely to have heart defects.

The FDA requests that doctors do not prescribe the drug to pregnant women in their first trimester unless the benefits outweigh the risk.

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Source: “FDA Strengthens Warning on Antidepressant Paxil.” The Associated Press. December 8, 2005.