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A Look At the Danish Study That Linked Zofran to Birth Defects

To date, there have been four studies on the popular anti-nausea medication Zofran (ondansetron) and its effect on unborn infants. As more and more infants are being diagnosed with birth defects associated with Zofran, more studies are expected to develop. One of the studies, an in-depth research project performed by Danish physicians and scientists, shows a strong correlation between pregnant women taking Zofran and a heightened risk of their infants developing birth defects.

2013 Danish Study

In August, 2013, Danish researchers released the results of a Zofran study that researched Danish births from 2004 and 2011. At least half of the women in the study took Zofran while pregnant. Afterwards, the researchers widened the search and included Danish births from 1997-2010. According to Dr. Gideon Koren, a pediatrician who led the study, infants who were exposed to Zofran while in utero were:

  • 2.3 times more likely to have ventricular septal defects
  • 2.1 times more likely to develop atrial septal defects
  • 4.8 times more likely to develop atrioventricular septal defects

Around 903,207 live births were included in the study. Approximately 1,368 of the pregnant women who gave birth during this time were prescribed Zofran during pregnancy, leaving 901,839 of the women unexposed to the medication. However, out of the women who took Zofran, 3.5% delivered an infant with a severe malformation. Another 4.7% of the women who took ondansetron while pregnant had infants with major birth defects. After combining these numbers together, the researchers indicated that there is a 20% increased risk of having a baby with congenital abnormalities if the infant’s mother takes Zofran while pregnant.

The risk of having a baby with congenital heart defects are even higher, as noted in the statistics above. Congenital heart defects can range from mild to severe and life threatening. The most common heart defect associated with Zofran are “hole in the heart” birth defects, in which the infant’s blood flow is affected, as well as his/her ability to receive nourishment and oxygen.

Congenital heart defects associated with Zofran include:

  • Coarctation of the Aorta
  • Pulmonary Atresia
  • Tetralogy of Fallot
  • Aortic Valve Insufficiency
  • Bicuspid Aortic Valve Disease
  • Cardiomyopathy

Zofran Not Intended for Pregnant Women

GlaxoSmithKline, the makers of Zofran, began marketing the medication as off-label use for morning sickness after finding an open market for the drug in pregnant women. However, the U.S. FDA has never approved Zofran use for pregnant women. In fact, the only people the medication is currently approved for are those undergoing cancer treatment options or surgery. Yet, each year, physicians continue to prescribe Zofran to pregnant women, despite study results that indicate it can cause birth defects. In addition, it’s been claimed that GlaxoSmithKline offered kickbacks to physicians in order to get them to prescribe the medication to pregnant women.

If you took Zofran while pregnant, keep in mind that you have the legal right to file for damages against the responsible party. Medical expenses alone for an infant born with birth defects can be overwhelming and costly, and more than the average family can afford. If your baby suffers via birth defects, you may be eligible for significant compensation to help you pay these medical costs, as well as pain, suffering, rehabilitation costs, lost wages, and more.