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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
  • 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.

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