Gideon Koren M.D. with the University of Toronto Department of Pediatrics lays out a review of various literature related to the links of Zofran and birth defects (additional studies have come out after February 2014 reaffirming his conclusions). Most importantly, he cites problems with a 2013 study (Pasternak) that found no statistically significant relationship between Zofran and birth defects. He emphasizes that HALF the data used in the study involved mothers that DID NOT ingest Zofran in the first trimester. The first trimester is widely supported as the time period when birth defects such as heart defects and cleft palate develop in the fetus. A different analysis of the same data group relied upon by Pasternak found statistically significant risks. Not to mention, that various other studies with controlled samples also found these risks.
Pasternak’s flawed study has resulted in doctors not recognizing the serious risks of Zofran and conveniently for GSK allowed them to continue to profit on sales. We hope the medical community heads Dr. Koren’s advice and uses safer alternative prescriptions to treat morning sickness such as doxylamine–pyridoxine.
These studies and the flawed analysis from Pasternak will have a central role in the litigation moving forward. If you have any questions or would like additional information related to risks of Zofran and pregnancy and the Zofran litigation, please contact our office at 1-800-882-2525 or email [email protected].