Studies Link Zofran to Birth Defects

In the past few years, several studies have identified a potential link between Zofran (ondansetron) and an increased risk of birth defects.

Harvard and Boston University Review

This 2012 epidemiological review of more than 10,000 birth records found that women who were prescribed Zofran as an off-label treatment for morning sickness were over twice as likely to have babies with cleft palate. Three specific treatments – proton pump inhibitors, steroids, and ondansetron – were found to warrant further investigation.

Danish Study 

In August 2013, a team of Danish researchers presented the results of a study they conducted to the International Conference on Pharmacoepidemiology in Montreal. Their paper, “Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations,” concluded that after ondansetron exposure, babies were:

• 1 times more likely to have atrial septal defects
• 3 times more likely to have ventricular septal defects
• 8 times more likely to have atrioventricular septal defects

Swedish Study

In 2014, a group of Swedish public health officials and researchers published a study on ondansetron’s potential effects on fetal development. They identified 1,349 children born to mothers who had been prescribed ondansetron during early pregnancy and compared their incidence of congenital malformations to those found among all births during the same time period. The conclusion: babies exposed to ondansetron have an increased and statistically significant risk of cardiovascular defects.

Australian Study

Australian researchers authored the 2013 study, “Off-Label Use of Ondansetron in Pregnancy in Western Australia,” and found a 20 percent increased risk of a major birth defect among children exposed to ondansetron in the first trimester. The researchers also found a dramatic increase in the risk for kidney malformations associated with ondansetron exposure.

Ondansetron has been sold in the U.S. under the brand name Zofran since 1991, and has never been FDA approved as a treatment for morning sickness.

Zofran lawsuits are currently being filed on behalf of children with serious injuries that may be attributed to the Mother’s use of Zofran during the first trimester of pregnancy.