While Zofran is approved by the United States Food and Drug Administration (FDA) for nausea and vomiting in cancer patients, many doctors have may have prescribed Zofran for off-label use to help with morning sickness in their pregnant patients.
Birth Defects Related to Maternal Drug Use
Babies born to mothers who used Zofran may be at a higher risk for birth defects. Some of the birth defects that were linked to maternal Zofran use include:
- Musculoskeletal anomalies
- Mouth deformities such as cleft lip and cleft palate
- Jaundice
- Heart defects such as holes in the heart
A 2011 study conducted with a grant from the Centers for Disease Control and Prevention (CDC) found that Zofran doubles the risks of birth defects overall. Another Danish study that included over 900,000 pregnant women who took Zofran, revealed that risk of infant heart defects increased two-fold. In two extreme cases, the drug has caused death.
