Researchers in the American Journal of Obstetrics & Gynecology (07/10) analysis set out to study whether the use of bupropion, the generic form of Wellbutrin, early in pregnancy was linked to an increased risk of congential heart defects. Bupropion is approved as an antidepressant, but is also used as a smoking cessation aid under the brand name Zyban. Both are marketed by GlaxoSmithKline. Because major depression among women who are of reproductive age is common and because women who smoke are encouraged to stop when they either become pregnant or plan on becoming pregnant, researchers determined that some women might be treated with bupropion early in their pregnancy.
Researchers noted, however, that despite the use of bupropion to treat pregnant women, there was only limited data on whether use of the medication while pregnant was safe. One source of data was the Bupropion Pregnancy Registry, established by GlaxoSmithKline in 1997 to report outcomes on pregnancies involving bupropion.
"By the end of March 2008, congenital anomalies had been reported in 24 of 675 (3.6%) infants of women identified prospectively to have taken bupropion in the first trimester and reported to the registry," researchers wrote. Among those were 18 live births with birth defects, one fetal death with a birth defect and five induced abortions with birth defects. Of those with birth defects, researchers report that congenital heart defects were observed in nine infants.
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Researchers concluded that the risk of left outflow tract heart defects could be as much as double in infants exposed to bupropion early in pregnancy. But they cautioned that more research should be conducted to confirm their findings.