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Zofran
(Ondansetron)

What Is Zofran?

      Zofran (ondansetron) is a prescription medication manufactured by GlaxoSmithKline (GSK) that prevents or treats nausea.  Originally marketed in the United States in 1991, the drug is only approved for use in treating nausea and vomiting after chemotherapy, radiotherapy or after surgery.  Despite the lack of approval, doctors have prescribed the drug for off-label (unapproved) uses such as morning sickness in expectant mothers. About 80 percent of pregnant women experience nausea and vomiting during pregnancy.  Recognizing a new market of patients for its drug, GSK advertised to doctors and mothers-to-be looking for relief from these symptoms. GSK made hundreds of millions of dollars annually from the medication.

 

What Are the Side Effects of Zofran?

      Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but in the past few years, results from a number of studies have surfaced linking Zofran to serious, congenital birth defects, including, physical deformities (like cleft palates and clubbed feet), hearing loss, vision loss, heart defects and mental problems, among others.

 

      Because Glaxo never proved the drug was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its product for morning sickness.  Some mothers found out too late about the dangers of the drug.