Zofran (ondansetron) is an anti-emetic, commonly used to treat nausea and vomiting in post-surgical and cancer patients suffering the side effects of chemotherapy and radiotherapy. Drug manufacturers GlaxoSmithKline soon discovered another target market- nearly 80 percent of pregnant women experience nausea and vomiting during pregnancy (NVP). The most serious form of NVP, called hyperemesis gravid arum, can lead to malnutrition and dehydration –dangerous for both the mother and the baby. GlaxoSmithKline began recommending the use of Zofran for pregnant women suffering from morning sickness or hyperemesis gravid arum. The use was off-label, meaning that no previous testing had been done and it lacked FDA approval. But that didn’t stop the drug giant from claiming the drug was safe for pregnant woman and their unborn children.
Since the off-label use, numerous birth defects have been reported, including
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Cleft palate/cleft lip
- Kidney defects
- Musculoskeletal defects
- Craniosynostosis (skull deformities)
- Fetal growth restriction
Birth defects can be life changing, and permanent. Court documents show GlaxoSmithKline was aware from as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies as the drug passes through the placenta. Despite this information, the drug maker continued to market the drug to pregnant women.