A recent study by Gideon Koren, M.D., from the University of Toronto Department of Pediatrics provides a review of assorted literature related to Zofran use and the development of birth defects. Crucially, Dr. Koren cites problems with a 2013 study conducted by Pasternak that found no statistically significant relationship between a mother’s use of Zofran and birth defects.
Dr. Koren emphasizes that half of the data used in the Pasternak study involved mothers that did not consume Zofran during the first trimester of their pregnancy. This is important as it is widely supported that the first trimester is the time period when birth defects such as cleft palate and heart defects form in the fetus. A different analysis of the data relied upon by the flawed Pasternak study found statistically significant risks associated with Zofran.
Zofran is a drug used to treat nausea but has never been studied in pregnant women. In 2006, Hong Kong researchers confirmed that Zofran could pass through the placenta when used during pregnancy. Since the 2006 study, several other studies have indicated that Zofran increases the risk of birth defects, including a 2011 study which linked Zofran with a 2.4 fold increased risk of cleft palate.