Zofran (ondansteron) is a medication approved to treat nausea and vomiting during chemotherapy therapy or following major surgery. Zofran is in a class of medications called 5-HT3 receptor antagonists. The drug works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Zofran During Pregnancy
Roughly 10-15% of pregnant women receive prescription drugs to treat morning sickness, according to a recent U.S. study. The powerful drug Zofran has been prescribed extensively "off-label" by physicians to pregnant females to treat nausea and morning sickness. However, Zofran was not approved to treat pregnant women and there are studies which suggest a link between the drug and serious birth defects when taken during pregnancy.
In a newspaper article published in the Toronto Star in June of 2014, investigative reporters revealed that the use of Zofran in pregnant women had been the subject of several studies during the last decade. The results have been conflicting due, in part, to the size of the samples and the interpretation of the data collected. The studies that did reflect an association between Zofran and severe birth defects included an increased risk "for a cardiovascular defect and notably cardiac septum defect" and higher odds of cleft palate in children born to women who ingested Zofran during the first trimester of pregnancy. It should be noted that the manufacturer has never conducted a large scale study regarding the safety of Zofran when prescribed to expectant mothers.
Off-Label Use of Zofran
The controversial yet common practice of off-label use of a drug means the drug is prescribed for a condition or population for which it has not been approved. Generally speaking, off-label prescriptions are written by doctors despite the lack of scientific documentation that the drug will be safe or effective. Drug companies and their sales representatives are forbidden to promote such uses of their product. Still off-label promotion occurs frequently with many different prescription drugs.
In fact, GlaxoSmithKline, the manufacturer of Zofran, was investigated by the Department of Justice (DOJ) for promoting off-label uses for various prescription drugs including Zofran. A civil lawsuit was filed by the DOJ against GSK which included allegations of off-label promotion of Zofran and other prescribed medications. There were also criminal charges filed against GSK for drugs other than Zofran. In the civil lawsuit, the DOJ alleged that GSK unlawfully promoted certain prescription drugs, it failed to report certain safety data, and alleged false price reporting practices.
In 2012, GSK pled guilty to criminal charges regarding the drugs Paxil, Wellbutrin and Avandia. GSK paid the U.S. government a total of $3 billion. Two-thirds of the money was to resolve the civil suit which included allegations of promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. GSK admitted no wrongdoing in connection with the civil suit.
While drug manufacturers and their sales representatives are not legally permitted to promote off-label uses for prescribed medications, there is no law or regulation preventing doctors from this practice. In many instances, this can lead to helpful solutions for patients. In the civil suit mentioned above, the DOJ had a theory that the rise in off-label prescriptions of Zofran for pregnant women resulted from GSK and its sales representatives directly marketing the drug as a safe and effective treatment for nausea and vomiting in pregnant women. GSK never admitted anything in regard to this accusation. However, there was apparently a rise in the prescriptions written for Zofran. And, the issue with Zofran is that the benefits may far outweigh the risks posed to the mother (especially during the first trimester) and her unborn child in some cases.
Facts About Zofran
- Used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.
- Is in a class of medications called 5-HT3 receptor antagonists. Works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
- Available as 4 mg and 8 mg tablets, 4 mg and 8 mg orally disintegrating tablets, and oral solution (4 mg/5 mL). Also available as an injection for intravenous use (2 mg/mL).
Zofran Safety Information from the FDA
- FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products
- FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)
- FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron)
- FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms may be associated with use of Zofran (ondansetron)
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.
Tampa Zofran Attorneys
The Tampa personal injury attorneys at Alley, Clark & Greiwe have an average of over 30 years of experience in litigating drug and medical device claims. If you or someone you know was prescribed Zofran during pregnancy who later delivered a child with serious birth defects, please contact Alley, Clark & Greiwe for a free consultation regarding your legal rights.