Did you or a loved one take Zofran during pregnancy? Here are 12 core facts you should know about Zofran:
1. GlaxoSmithKline (GSK) manufactured Zofran (active ingredient: Ondansetron Hydrochloride).
2. In the 1980s, GSK performed Zofran testing on rabbits and rodents. These tests showed evidence of toxicity, malformations, and intrauterine deaths in the animals.
3. In 1991 The Food & Drug Administration (FDA) approved Zofran for sale in the United States to patients who were suffering from extreme nausea as a result of chemotherapy, radiation therapy, and for certain post-operative procedures.
4.The FDA never approved Zofran as a drug for morning sickness that was safe for pregnant women.
5. GSK did not take Zofran through an approval process for the drug to be given to women for morning sickness. GSK commenced marketing Zofran from 1991 onward as a “safe” solution to vomiting, nausea, and morning sickness during pregnancy.
6. In 1990, GSK was notified of 2 birth defects caused by mothers ingesting Zofran during the first trimester of pregnancy.
7. By the year 2000, GSK was aware of 32 reported instances of a birth defect attributed to Zofran ingestion by the birth mother for morning sickness. As of today, there are over 200 reported defect cases.
8. Several epidemiological studies were performed from the 1990’s onward which may support a link between Zofran and child birth defects, in particular, cleft palate, cleft lip, and congenital heart defects.
9. GSK has never performed any clinical trials on Zofran in pregnant women to gain FDA approval. GSK has never modified the Zofran label with warnings of child birth defects.
10. In 2012, GSK settled claims brought by the US Government and paid a record high $3 billion fine. This settlement included the allegations for the marketing of Zofran to pregnant women who were suffering from morning sickness, and included allegations of paying kickbacks to physicians to prescribe Zofran for morning sickness.
11. GSK continues to deny all allegations relating to Zofran causing birth defects. GSK has offered no warnings that the drug is unsafe for pregnant women and has not asked the FDA to do so either.