FDA warns pregnant women that Paxil can lead to birth defects

• The advisory is based on early results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall.
• "If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," said Robert Temple, the FDA's director of medical policy.
• In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil.
• Since a large number of pregnant women suffer some form of depression -- some estimates are as high as 20 percent -- decisions about whether to start or continue on antidepressants are increasingly common and difficult.
• Adding to the complexity of the decision, an earlier study published in the Journal of the American Medical Association found that the babies of mothers taking antidepressants were three times more likely to suffer from irritability, tremors and seizures in the weeks after birth.
• An initial analysis of that large database found no correlation between birth defects and use of SSRIs, but a follow-up study found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all.
• Glaxo spokeswoman Gaile Renegar said the company is studying how and why its drug might be causing these defects, adding that it remains unclear whether there is a cause-and-effect relationship.
• American regulatory officials have generally been slower to issue warnings about antidepressants than their counterparts in other countries, especially in Britain and Canada.