WEDNESDAY, Feb. 27 (HealthDay News) -- A drug commonly used to treat severe cases of morning sickness does not appear to be linked to birth defects or other risks to the baby, a large new study suggests.
The Danish researchers said the findings, reported in the Feb. 28 issue of the New England Journal of Medicine, do not prove the medication is risk-free. But they said the study should reassure women who need the drug, called ondansetron (Zofran and generics).
"We can never say it's 100 percent safe," said Christina Chambers, co-director of the Center for Promotion of Maternal Health and Infant Development at the University of California, San Diego.
"But this is a good study that really adds to what we've known," said Chambers, who was not involved in the work.
The findings are based on records from more than 600,000 Danish women who were pregnant between 2004 and 2011. Of those women, about 0.3 percent received prescriptions for ondansetron. About half had nausea and vomiting severe enough that they had been hospitalized.
Overall, there was no evidence that the medication increased the risks of miscarriage, stillbirth, preterm delivery or major birth defects, according to the researchers, led by Dr. Bjorn Pasternak of the Statens Serum Institute in Copenhagen.
Of women given the morning-sickness drug in the first trimester, for example, just over 1 percent had a miscarriage, versus almost 4 percent of women who did not take the medication. And in both groups, 3 percent of moms had a baby with a major birth defect, such as a heart defect or malformations of the brain or spine, including spina bifida.
The study, which was funded by the Danish Medical Research Council, has its limits, Chambers said. It is observational, meaning it relied on women's medical records and looked for correlations between ondansetron prescriptions and risks to the developin
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