Update: December 8, 2005 - The Food and Drug Administration has reclassified the antidepressant Paxil after studies link it to a slightly elevated risk of fetal heart defects in babies whose mothers took the drug during the first trimester of pregnancy. The new classification, a "category D drug," means there is a known risk during pregnancy.


Drugmaker GlaxoSmithKline has sent a letter to doctors advising them the antidepressant Paxil may be linked to a slightly higher risk of birth defects in babies exposed during the first trimester of pregnancy. Although the findings are preliminary, the company has added a new warning to its label.

GlaxoSmithKline, described the findings as a surprise. Other studies had shown no increase in birth defects.

This time, the company looked at data from more than 3,500 pregnant women taking antidepressants. It found four percent of the women taking Paxil had babies born with birth defects, compared to two percent taking other antidepressants. For comparison, the rate of birth defects in the general population is about three percent. In this study, the most common birth defects with Paxil were heart problems.

The The U.S. Food and Drug Administration's Dr. Sandra Kweder says the agency had requested the study, but it was also surprised by the results.

"I think that's one of the reasons why they said 'Oh my goodness, this is an interesting finding,'" says Kweder. "So you know, it does conflict with other information that's been available. But for that reason, we decided better to be safe and put that information out there."

The FDA has posted Glaxo's letter on its Web site, but Kweder adds the Paxil label has always warned doctors to weigh the potential risks and benefits of prescribing drugs in this class during pregnancy.

Dr. Lee Cohen, a perinatal psychiatrist at Massachusetts General Hospital, cautions that the new findings don't mean pregnant women who are currently taking Paxil should go off the drug. He says exposing a baby to the mother's depression is also a health risk.

"If one had a choice for patients planning to conceive," says Cohen, "it's probably prudent to be on an antidepressant for which we have the most reproductive safety data supporting the absence of any particular adverse effect and that would be for Prozac and Celexa."

Last year, another warning about antidepressants and pregnancy was issued. Babies exposed to the drug at the end of pregnancy could suffer from withdrawal. Dr. Sandy Zeskind, who directs neurodevelopmental research at Carolinas Medical Center, says the latest study on Paxil shows there is a need for further research on antidepressants and pregnancy.

"I'm glad to see that someone is looking at other aspects of outcome than what had been looked at before and I have long suspected that there would be other measures of poor developmental outcome. It's just a matter of looking at them," says Zeskind.

The new precaution about Paxil during pregnancy gives mothers like Lisa Sedlak one more piece of information to evaluate when planning a pregnancy. Sedlak took Paxil during her last pregnancy and had a healthy baby girl. Sedlak says she wants to have more children, and doubts the new precaution will influence her decision about whether to continue taking Paxil.

"I'm a very skeptical type person," says Sedlak, "so when I hear that there's a slight increase, it's like, 'Oh, it's a slight increase.' Three percent to four percent is not enough of a concern for me. Especially when it comes down to me being happy and healthy, because if I'm miserable mentally, I might do something to harm myself or my child, and I don't want to go through that."

The FDA says it will review the new information about Paxil and pregnancy over the next few months to decide whether the additional warning on the label is sufficient.

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