Zofran (ondansetron), manufactured by GlaxoSmithKline, is a member of a class of drugs known as 5-HT3 receptor antagonists, which work by blocking the actions of serotonin. Zofran was approved by the Food and Drug Administration (FDA) in January 1991, to treat chemotherapy-related nausea, and the approval was later expanded to treat postoperative nausea and vomiting.
According to recent allegations, it is believed that Zofran has also been marketed and prescribed for off-label uses, such as use by pregnant women suffering from morning sickness. According to a recent article published by the American Journal of Obstetrics & Gynecology, “Presently 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration.”
Studies show that Zofran use by pregnant women can lead to a heightened risk of severe birth defects, including heart development irregularities, cleft lip and cleft palate.
If you feel you have experienced any side-effects from taking Zofran, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Zofran manufacturers.