For additional Zofran information, visit our other Zofran pages: Zofran and birth defects, Zofran Lawsuits, Should I Take Zofran While Pregnant?, or What Types of Birth Defects are Associated with Zofran Use?
Zofran Initially Approved for Cancer Patients
When Zofran became available from GlaxoSmithKline (GSK) in the United States in 1991, it was FDA approved for use in treating nausea mainly in cancer patients undergoing chemotherapy. But soon after its release, GSK marketed it for the “off-label” use of treating nausea in pregnant women experiencing morning sickness. Unfortunately, GSK did not perform any studies or research on the effects of Zofran on pregnant women and the fetus prior to marketing it for such “off-label” use.
Studies Suggest Birth Defect Link
Many have speculated about the possible effects of Zofran on pregnant women. Some recent studies are presented below:
2006 Hong Kong Study: In 2006, a group of Hong Kong researchers who sampled 41 pregnant women concluded that Zofran passes through the placenta during the first trimester of pregnancy. Zofran was detected in the fetal tissue of every woman sampled for the survey.
2013 Danish studies: In August of 2013, a research group from Denmark revealed conclusions from a study of approximately 900,000 pregnant women from the years 1997-2010. The study found that there was risk of cardiac defects associated with Zofran which lead to a 30% overall increase of major cardiac defects in newborns. To the contrary, another study performed by researchers at the Statens Serum Institute in Copenhagen found that Zofran was safe for pregnant women to take. This specific study included the analysis of approximately 600,000 participants.
2014 American Journal of Obstetrics and Gynecology: A study by Dr. Gideon Korean commented on the conflicting studies about Zofran and risks of pregnant women taking it. These risks include birth defects like cleft palate, clubfoot, malformed skull, and heart defects.
Additional Studies Warranted
Presently, many believe that there is insufficient information about the possible risks associated with taking Zofran to have a clear answer. But the Centers for Disease Control and Prevention (CDC) has issued a warning of the possible prospects on birth defects related to ondansetron, stating that further research was needed , and the FDA has reiterated that it does not condone prescribing medicines off label. And yet many women are still being prescribed this medication without a clear understanding of the potential consequences. Over time, additional research will likely present a clearer picture of the relationship between Zofran and birth defects.