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Zofran (Ondansetron) and the Risk of Birth Defects

Zofran and the risk of birth defects

DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.

History and Use

Zofran (ondansetron), a drug manufactured by GlaxoSmithKline, was approved by the FDA in 1991 to treat nausea caused by chemotherapy.  The drug was later approved by the FDA to treat postoperative nausea and vomiting (PONV).

Zofran is a 5-HT3 receptor antagonist which, according to WebMD, “…works by blocking the effects of a chemical called serotonin, which is produced in the brain and the stomach.”  Although Zofran is approved for PONV and chemotherapy nausea, it is often prescribed to treat morning sickness or nausea and vomiting during pregnancy (NVP).

Zofran has not been approved by the FDA for use in pregnant women.

What are the Concerns?

Recent reports and studies suggest a link between Zofran use during pregnancy and birth defects. These birth defects include (but are not limited to):

  • Cleft Palate
  • Cleft Lip
  • Congenital Heart Defect
  • Death

Studies and Reports

Toronto Sun

A June 2014 article in the Toronto Sun examined 20 cases of women who were prescribed ondansetron for vomiting related to pregnancy.  The reporters found that the women “…experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations.”

Alarmingly, the manufacturer of Zofran, GlaxoSmithKline, has gone on record to state, “the safety of ondansetron for use in human pregnancy has not been established.”

National Birth Defects Prevention Study

According to the Centers for Disease Control, the National Birth Defects Prevention Study (NBDPS) “is one of the largest studies on birth defects ever undertaken in the United States.” The National Institute of Health analyzed data from the study in an effort to determine whether nausea and vomiting during pregnancy (NVP), or its treatment, was associated with the most common non-cardiac defects (non-syndromic cleft lip with or without cleft palate, cleft palate alone, neural tube defects, and hypospadias). The study concluded that NVP itself was not associated with an increased risk of birth defects, but that there are possible risks of defects when NVP is treated with drugs such as Zofran (ondansetron).

New England Journal of Medicine

A February 2013 study published in the New England Journal of Medicine tracked 600,000 women with the goal of investigating the risk of adverse fetal outcomes associated with ondansetron administered during pregnancy.  This study found no increased risk of spontaneous abortion, stillbirth, or any major birth defect.

Danish Study 

A group of doctors studied the effects of ondansetron on all births in Demark between 1997 and 2010.  The results indicate that the babies studied were twice as likely to have major congenital heart defects if the mother had redeemed a prescription for ondansetron during the first trimester of the pregnancy.

Zofran Warning Label

The manufacturer of Zofran, GlaxoSmithKline, lists the following warning for potential users who may be pregnant: “There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”

If you or a loved one was injured as a result of using Zofran during pregnancy, call 1-888-505-8232 or click here to contact us through our website.  If you have questions or are just looking for information, we are here to help.  We never charge a fee to answer questions or help you find answers.

DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.