Does Zofran cause birth defects? Several studies have found birth defects to be among the possible ondansetron side effects when taken by pregnant women. Zofran, the brand name of ondansetron, is a strong anti-nausea drug. It has been routinely prescribed for pregnant women experiencing morning sickness, although its FDA approval did not include use by expectant mothers. The drug has been linked to a drastic increase in the risk for congenital heart defects and cleft palate.
Listed as a Category B medication for pregnant patients, Zofran does not have indications of toxicity in animal studies. However, it has not yet been proven safe for use during pregnancy. Studies show ondansetron crosses the human placenta, and as a result, may affect developing fetuses. As such, the babies of women who took Zofran during pregnancy may suffer from ondansetron side effects, such as malformation and other birth defects.
A cleft palate is a hole in the roof of a baby’s mouth that occurs when the tissues that make up the upper part of the roof of the mouth fail to join completely. It can cause hearing, feeding, and speech problems as well as ear infections. Surgery is often needed to correct the problem.
One medical study linked Zofran use during the first trimester to a 237% increased risk for cleft palate defects.
These defects can be fatal to newborns or may escape detection for years. Examples include atrioventricular septal defect (defect in which holes exist between the heart’s chambers) and pulmonary valve stenosis (narrowing of the valve that pumps blood to the lungs).
Two studies revealed that babies whose mothers used Zofran were 1.6 times more likely to develop a congenital heart defect. Newborns faced 4.8 times higher risk of atrioventricular septal defects and approximately two times higher risk of ventricular or atrial septal defect if their mothers took Zofran while pregnant.
There are more than 400 Zofran-related lawsuits filed against GlaxoSmithKline (GSK), the company that originally marketed the use of the drug for morning sickness. The lawsuits allege that GSK breached its duty to warn patients and doctors about Zofran’s dangers and promoted its off-label usage to expectant mothers, who were at the highest risk of the drug’s side effects.
Zofran has hurt many people across the United States. Victims who have suffered from its side effects have been pursuing compensation for:
For children born with congenital heart defects or a cleft palate and their mothers took Zofran during pregnancy in Chicago, a birth injury attorney can help with seeking compensation for the defects.