Zofran Study Says its Safe for Pregnant Women—But Maybe Not

A two-year-old study made about Zofran (ondansetron) concluded that there was no evidence that the drug posed any risk of birth defects in children of women prescribed with it for severe nausea and vomiting of pregnancy (NVP) or morning sickness. However, an extension of the same study by another group of researchers concluded the opposite. So which is it?

The study Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes was published in the February 2013 issue of the New England Journal of Medicine. It made use of records from the Danish Birth Registry between 2004 and 2011, where each of the 1,970 women exposed to ondansetron were matched to 4 control cases. The researchers concluded that no adverse fetal outcomes were associated with ondansetron use.

This was welcome news for women that had already taken the drug in the first trimester of their pregnancy. However, the same study was presented to the International Society of Pharmacoepidemiology in Montreal six months later using a larger number of women over a longer period of time (1997 to 2010) from the same registry. The results of that study indicated that there was a two-fold risk of adverse fetal outcomes associated with ondansetron.

Which study should be believed? At this point, it is a toss up. Common sense dictates that pregnant women should avoid Zofran altogether until there is a definite conclusion either way. There are alternative medications to alleviate the symptoms of NVP that are safe for pregnant women. At any rate, the Food and Drug Administration (FDA) does not approve Zofran for NVP, so that should be an indication to stay away.

However, according to the website of Williams Kherkher, if this warning comes too late, you can still address the issue. If you were prescribed with Zofran while pregnant and your child has birth defects, contact a dangerous drug lawyer in your area immediately to discuss how to get compensation.

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