With Zofran lawsuits mounting in U.S. courts, many might be wondering if the anti-nausea medication should ever be prescribed to pregnant women. Last year, one medical expert answered that question with an unequivocal “No.”
Writing in the American Journal of Obstetrics and Gynecology in August, Dr. Gideon Koren, the founder of MotherRisk, a Canadian program that has become leading world authority on drugs and pregnancy, pointed out that as many as 1 million expectant mothers in the U.S. are prescribed Zofran or a genetic equivalent every year. Though the drug has never been approved to treat pregnancy-related nausea and vomiting, the absence of any approved treatment in the U.S. until recently meant that alternatives were few. Not surprisingly, the use of ondansetron among pregnant women has increased from 50,000 prescriptions per month in 2008 to 110,000 at the end of 2013.
Dr. Koren’s article does a good job detailing the conflicting research findings regarding the possible association between Zofran and birth defects. In 2004, a small study involving just 176 expectant mothers found no risk. But because of the way the study was designed, only a 5-fold increased risk of major malformations could be ruled out. Any association with certain specific birth defects also could not be eliminated.
In 2013, two separate studies involving the same Danish health registry produced conflicting results, with one finding no link between ondansetron and birth defects, By contrast, the second suggested the drug was associated with a 2-fold increased risk of cardiac malformations, and a 30% increased risk of birth defects overall. Dr. Koren points out that the second study covered more years (1997-2010) and more pregnant women (897,018 vs 608, 835).
Finally, Dr. Koren notes that in 2013, the U.S. Food & Drug Administration (FDA) approved a combination of doxylamine and pyridoxine (sold under the brand name Diclegis) to treat pregnancy-related nausea and vomiting. Diclegis has been placed in Pregnancy Category A, which indicates that “adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy. By contrast, Zofran is listed in Pregnancy Category B, which means that “there are no adequate and well-controlled studies in pregnant women.”
A number of Zofran lawsuits are currently pending in U.S. courts that accuse the drug’s manufacturer of concealing its association with birth defects. If you suspect that Zofran hurt your baby, please call (888) 881-3077 to learn more about this growing litigation.