Zofran Birth Defects Information for Montana Residents

Risk of Serious and Life-threatening Birth Defects Linked to Prenatal Zofran Exposure

Zofran (ondansetron) is an anti-nausea drug that has been linked to a risk of birth defects when taken during pregnancy. Zofran birth defects research indicates that fetuses exposed to Zofran may face a two-fold increase in risk for a range of birth defects including heart defects, physical abnormalities including cleft lip and cleft palate, atrial septal defect, fetal growth restriction, low birth weight, and jaundice.

Approved for use in patients undergoing chemotherapy, radiation and surgery, Zofran is widely prescribed off-label to control extreme nausea in pregnant women. For many women, nausea peaks in the first trimester, which is also a highly sensitive period of fetal development. Research shows that fetuses exposed to Zofran in utero, particularly during the first trimester, are at risk for developing birth defects.

Types of Zofran Birth Defects

A study that examined pregnancy outcomes of over 900,000 women in Denmark found that fetuses exposed to Zofran during the first trimester of development face a doubling in the risk of heart defects compared to fetuses not exposed to the drug. The following congenital heart birth defects and other birth defects that have been linked to Zofran exposure:

• Atrial septal defect: this birth defect is characterized by an opening in the septum between the upper-left and upper-right chambers of the heart, known as the atria


• Ventricular septal defect: Commonly referred to as a “hole in the heart”, ventricular septal defect is characterized by a birth defect located between the lower-left and lower-right chambers, known as the ventricles


• Heart murmur: an abnormality in the heart beat that can be dangerous


• Cleft palate and cleft lip have also been associated with Zofran exposure during the first trimester. Cleft palate is a birth defect characterized by a gap in the roof of the baby’s mouth and can affect the nasal cavity, gums and upper lip. Cleft lip is a birth defect limited to the upper lip. Cleft palate and cleft lip range dramatically in severity and in extreme forms can have significant implications on an infant’s health and ability to thrive.


• Other birth defects linked to Zofran through scientific research include musculoskeletal defects and jaundice.

Zofran Birth Defects & the FDA

To date, Zofran has not been approved for use in pregnant women. In fact, Zofran has been under FDA scrutiny since 2013 when a pattern of adverse event reports (heart arrhythmias and serotonin syndrome) was detected by federal regulators through its FAERS system. Zofran is categorized as a Pregnancy Category B drug, meaning there is inadequate testing on the safety of the drug for prenatal women.

Zofran was developed by GlaxoSmithKline and was first approved by the FDA in 1991. Generic versions of the drug entered the U.S. market in 2006. Zofran is in the 5-HT3 receptor antagonist class of medicines. It controls nausea and vomiting by blocking the function of serotonin, the chemical responsible for causing these conditions. Zofran can be taken in a rapidly-disintegrating tablet or via injection.

Zofran in Pregnancy and the U.S. Department of Justice

In 2012, the U.S. Department of Justice (D.O.J.) filed a lawsuit against GlaxoSmithKline over the off-label marketing of Zofran and other drugs. Off-label marketing refers to marketing conducted to promote Zofran for uses other than those approved by the FDA. Among those off label applications was the use of Zofran to treat morning sickness in pregnant women. Ultimately, GlaxoSmithKline paid $3 billion to the DOJ to resolve numerous criminal and civil charges, and has been subject to stringent requirements to ensure to corporation is adhering to federal regulations.

“Today’s historic settlement is a major milestone in our efforts to stamp out health care fraud. For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.”

Zofran Birth Defects Research

Existing research on the effects of Zofran on pregnant women and fetuses indicates this application is not safe. However, mixed results from a variety of studies have served to confuse the public about the actual risk of Zofran birth defects. Studies conducted with a very small sample size have concluded that Zofran birth defects are not a risk. However, large studies show there is a risk of birth defects from prenatal exposure to Zofran. To date, Zofran has never been approved for use in pregnant women in the United States.

Timeline of Zofran Birth Defects Research

• 2004: Motherisk in Canada produced a study indicating no link between Zofran and birth defects. The study, which included only 200 mothers, was the only existing research until 2013.


• January 2012: A peer-reviewed study published by the Center for Birth Defects Research & Prevention and conducted by Slone Epidemiology in Boston and the Centers for Disease Control and Prevention in Atlanta examined select anti-nausea drugs and birth defect rates, finding that first trimester exposure to Zofran resulted in an increased rate of cleft palate from Zofran use by the mother.


• February 2013: The New England Journal of Medicine published a study based on select Danish birth records dating from 2004 – 2011. This study did not detect a link between Zofran and birth defects. Critics say the study had too small a sample size, and many of the women didn’t start taking Zofran until after Week 10 of their pregnancy, at which time fetuses are no longer at risk for developing major birth defects.


• August 2013: Another group of researchers published a study on Zofran birth defects based on the same Danish birth records data, expanding their scope to examine records ranging from 1997 through 2010. This study, which is by far the most comprehensive study on Zofran birth defects, found the drug doubles the risk of congenital heart defects and increases the risk of birth defects overall by 30%. The sample group included 1,248 women who took Zofran during their first trimester of pregnancy.

Montana Zofran Birth Defect Lawyers Offer Free Case Review

Our attorneys handling Montana Zofran birth defect lawsuits on behalf of mothers and families whose babies suffered birth defects after exposure to Zofran. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or a loved meets this description, complete the contact form at the right of your screen and a Montana Zofran birth defects attorney will respond to answer your questions and giving you a sense of your legal options. Montana Zofran birth defects attorneys provide free, no-obligation case review.

Montana Zofran Birth Defects Lawsuits

Individuals and families in Montana whose baby was born with a birth defect from Zofran may have grounds to file a lawsuit. We provide legal representation for Montana Zofran birth defects lawsuits on a contingency basis, meaning that we never charge a fee unless we win compensation on your behalf.