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.
