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Women who take a common type of antidepressant during the second half of their pregnancy are about six times more likely to give birth to a baby with a rare but potentially fatal heart and lung condition, a study reports today.
The Food and Drug Administration's Sandra Kweder called a news conference Wednesday to praise the study and say the agency expects to issue a public health advisory based on the "worrisome" finding. The FDA also is considering asking manufacturers to add a warning to the antidepressants' labels and conduct postmarketing studies of their use during pregnancy, Kweder said.
In the study, scientists enrolled 377 women whose babies had persistent pulmonary hypertension of the newborn, or PPHN, which occurs in an estimated one or two infants per 1,000 live births.
In babies with PPHN, the circulatory system hasn't made the normal transition from its prenatal state. Before birth, the fetus receives oxygen-carrying blood from the placenta, so the circulation bypasses the lungs.
In an earlier study of 155 full-term babies with PPHN, 11 died, and nearly half of the survivors had serious consequences such as major brain abnormalities and hearing loss, according to an editorial accompanying the new study. The articles appear in The New England Journal of Medicine.
Christina Chambers, the study's lead author, says she and her colleagues began to suspect a possible link between serotonin-reuptake inhibitors, or SSRI drugs, and the condition a decade ago.
In a 1996 study, they found two cases out of 73 babies born to women who took Prozac, which was then the only SSRI on the market, through their pregnancies.
The new study includes women who took Prozac as well as Zoloft, Paxil or Celexa for at least halfway through their pregnancies. For comparison, the researchers enrolled 836 women with healthy infants. Nurses who did not know the hypothesis interviewed the women about their medication use during pregnancy and potential confounding factors, such as health history.
The study found that 14 babies with PPHN were born to mothers who had taken an SSRI after their 20th week of pregnancy. Only six of the healthy babies' mothers had taken an SSRI after that point.
Even when women take SSRIs late in pregnancy, the risk of the condition is only about 1%, says Chambers, a University of California-San Diego researcher who runs the California Teratogen Information Service. "The uppermost message is: Don't panic," she says. "You can take in this information and certainly discuss it with both your obstetrician and your mental health provider."
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