Warning on Paxil

The U.S. Food and Drug Administration has sent out a warning on the medicines Paxil (paroxetine) and Paxil CR. These antidepressants are used to treat depression. Taking Paxil or Paxil CR during the first 12 weeks of pregnancy may increase a woman's chance of having a baby with a birth defect. The maker of the medicine, GlaxoSmithKline, has changed the label on the medicine to reflect this.

The warning came after the maker of Paxil did a study to see if the medicine was safe for pregnant women. The study looked at 3,581 pregnant women. It found that 4 in 100 women who took Paxil or Paxil CR during the first 12 weeks of pregnancy had babies with birth defects. The risk of birth defects for most pregnancies is 3 in 100.

If you take Paxil or Paxil CR and are pregnant or are planning to get pregnant, talk to your doctor. Do not stop taking Paxil or Paxil CR unless you talk to your doctor first.

Last Updated: March 13, 2009

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