Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
There is an increased chance of cardiac abnormalities when a child is exposed to Zofran (ondansetron) while in utero. This information is found in the May 2016 article recently released by Obstetrics & Gynecology, "Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review" (subscription or payment may be required for full article text).
Here are the conclusions of the aforementioned article, as mentioned in the Abstract:
The overall risk of birth defects associated with ondansetron exposure appears to be low. There may be a small increase in the incidence of cardiac abnormalities in ondansetron-exposed neonates. Therefore, ondansetron use for nausea and vomiting of pregnancy should be reserved for those women whose symptoms have not been adequately controlled by other methods.
These findings were derived from various studies involving women who took Zofran in the early stages of their pregnancy to mitigate nausea and vomiting.
However, it is also important to note that some of the data collected in the studies analyzed by this article was conflicting. For example, the Practice Update article, "Review: Low Risk of Birth Defects With Ondansetron Exposure," states that "the three largest studies showed no increased risk of birth defects" and "the risk of cardiac defects was slightly increased" in two of these studies, but "this finding was not replicated in other studies."
In any case, women who are pregnant should be wary of taking Zofran for morning sickness during the early stages of their pregnancy, due to the possible chance that it could cause cardiac abnormalities in their unborn child.
We will continue to monitor the medical literature concerning the relationship between the risk of birth defects among the offspring of women who took Zofran in the early stages of their pregnancy.
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