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 FDA in 1991.
  • 30% increased risk of birth defects and a doubled risk of heart defects in infants.
  • September 2011, 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 FDA stated the drug should not be prescribed in an amount over 16 mg.

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