Zofran Use Associated with Certain Birth Defects

For additional information about Zofran use, visit our other Zofran pages: Zofran and birth defects, Zofran studies, Should I Take Zofran While Pregnant?, or Zofran Lawsuits.

Zofran, generically known as ondansetron, is a drug that is oftentimes administered to women during pregnancy to curb nausea and vomiting due to morning sickness. Even though this drug is commonly prescribed to pregnant women, the Food and Drug Administration (FDA) has not approved this medication for use during pregnancy. Historically, Zofran has been approved for use to treat nausea and vomiting in patients undergoing chemotherapy or radiation, as well as for post-operative sickness. Recently, there has been much discussion about a probable link between pregnant women who have taken Zofran, and birth defects in their children. Some studies have suggested that there may be a positive relation between the medicine and birth defects and that further research is warranted on this subject.

Some types of birth defects that are thought to be associated with Zofran use are: cleft lip or cleft palate, jaundice, musculoskeletal anomalies, and several types of heart defects including: Heart Murmurs, Atrial Septal Defect (ASD), and Ventricular Septal Defect (VSD).

Cleft Lip / Cleft Palate – Cleft lip and palate occur as a result of an incomplete formation of the front of the upper jaw and upper portion of the roof of the mouth.

Jaundice (AKA Icterus) – A buildup of bilirubin (the substance that carries oxygen in red blood cells) causing skin and eyes to turn yellow with the potential to do liver damage.

Musculoskeletal Anomalies – Deformity or malformation of the musculoskeletal system present at birth.

Heart Murmurs – A heart murmur is a condition that involves improper heartbeat contractions.

Atrial Septal Defect, or ASD – ASD occurs when the wall between the two upper heart chambers fails to fully close. Because of the incomplete closure between the two chambers, the infant is born with a gap in the heart. This “hole” could take multiple surgeries to repair and can lead to long term disabilities due to the lack of oxygen supply to the infant’s brain and body.

Ventricular Septal Defect, or VDS – VDS is similar to ASD except that the lower two heart chambers are affected by an incomplete closure of the wall.

Though there has been no conclusive study to show direct causation of these birth defects and Zofran use, it is recommended that you discuss the potential risks and possible alternatives with your physician.