Zofran/Birth Injury

  • Originally created to reduce nausea and vomiting in patients after chemotherapy, radiation, or other serious surgeries.
  • Prescribed to pregnant women to reduce nausea, though it has not been approved to treat morning sickness.
  • The generic name is Ondansetron, first approved by the Food and Drug Administration in 1991.
  • 30 percent increased risk of birth defects and a doubled risk of heart defects in infants.
  • In September 2011, the FDA announced that a 32 mg dose of Zofran can change the electrical chemistry of the heart and cause fatal heart rhythms.
  • The drug was recalled and the FDA stated the drug should not be prescribed in an amount over 16 mg.