Health Care


From NPR News, this is ALL THINGS CONSIDERED. I'm Michele Norris.

Drugmaker GlaxoSmithKline has sent a warning letter to doctors. It advises them that the anti-depressant Paxil may be linked to a slightly higher risk of birth defects in babies exposed during the first trimester of pregnancy. The company has also added the warning to its Paxil label. The move comes on the heels of a new study done for the Food and Drug Administration. Sasha Aslanian of American RadioWorks has that story.


The maker of Paxil, 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 anti-depressants. It found 4 percent of women taking Paxil had babies born with birth defects, compared to 2 percent taking other anti-depressants. For comparison, the rate of birth defects in the general population is about 3 percent. In this study, the most common birth defects with Paxil were heart problems.

The FDA's Dr. Sandra Kweder says the agency had requested the study, but it also was surprised by the results.

Dr. SANDRA KWEDER (Food and Drug Administration): I think that's one of the reasons why they said, `Oh, my goodness, this is an interesting finding.' So, you know, it does conflict with other information that's been available, but for that reason, we thought, well, better to be safe and put the information out there.

ASLANIAN: 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 the new findings don't mean pregnant women who are currently taking Paxil should go off the drug. Exposing a baby to the mother's depression is also a health risk, he says.

Dr. LEE COHEN (Massachusetts General Hospital): If one had a choice for patients planning to conceive, it's probably prudent to be on an anti-depressant for which we have, you know, the most reproductive safety data, you know, supporting the absence of any particular adverse effect, and that would be for Prozac and Celexa.

ASLANIAN: Last year another warning about anti-depressants and pregnancy was issued. Babies exposed to the drugs 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's a need for further research on anti-depressants and pregnancy.

Dr. SANDY ZESKIND (Carolinas Medical Center): 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.

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

Ms. LISA SEDLIKE (Christiansburg, Virginia): I'm a very skeptical type person, and so when I hear that there's a slight increase, I always, think, `Oh, it's a slight increase.' Three percent to 4 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, then I might do something to myself or to harm my child, and I don't want to go through that.

ASLANIAN: 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. For NPR News and American RadioWorks, I'm Sasha Aslanian.

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