Answers to frequently asked questions (FAQ) about Zofran, an anti-nausea drug that was marketed “off-label” to pregnant women with morning sickness. Recent studies have linked Zofran with birth defects and hundreds of lawsuits have been centralized in federal court.
Frequently Asked Questions (FAQ)
Does Zofran cause birth defects?
What birth defects are associated with Zofran?
What is the risk for a baby?
Can Zofran cause other pregnancy complications?
What studies have linked Zofran and birth defects?
Has the FDA issued warnings?
Is there an alternative?
Zofran is the brand-name for ondansetron, an anti-nausea and vomiting medication that is manufactured by GlaxoSmithKline (GSK). It works by blocking the action of serotonin.
No. Zofran is not approved for pregnant women with morning sickness, but it is used by around 1 million pregnant women every year. Zofran is a “Pregnancy Class B” drug that has never been studied for safety during pregnancy. T
In 2012, the FDA issued warnings about severe irregular heart rhythm in patients on 32-mg intravenous Zofran. This condition can cause sudden cardiovascular death within minutes.
Zofran changes serotonin levels and the FDA believes there is a potential risk of serotonin syndrome, especially in patients who are also on antidepressants. This side effect is easily misdiagnosed and can cause agitation, confusion, rapid heartbeat, muscle twitches, fever, unconsciousness, and coma.
Yes, but not for causing birth defects. The FDA recalled 32-mg intravenous Zofran in December 2012 due to the risk of severe irregular heart rhythm.
In July 2012, GSK paid $3 billion to resolve civil liability for allegedly promoting Zofran “off-label” to pregnant women with morning sickness. GSK was also accused of paying kickbacks to doctors who prescribed Zofran.
No one knows if Zofran causes birth defects. Several studies have found higher rates of birth defects, but the risk is still relatively low. Health experts say Zofran should only be used as a last-resort medication for morning sickness after other treatments have failed.
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Hole in the heart
- Cleft lip
- Cleft palate
- Musculoskeletal Defects
- Fetal growth restriction (poor growth in the womb)
- Kidney defects
- And more
The risk is low. The average chance a baby will have cleft palate is about 1 in 2500. In babes exposed to Zofran, studies suggest the risk increases to 2-3 per 2500. Likewise, about 1% of all babies (1 in 100) are born with heart defects, and studies have linked Zofran with a 2% risk (2 in 100).
Studies have not found higher rates of miscarriage, premature birth, or low birth weight when women use it during pregnancy.
A major study linking Zofran and birth defects was published by Birth Defects Research in August 2013 by Dr. Jon Andersen. It was a re-analysis of data in another study that found no risk of birth defects.
The study found that Zofran doubled the risk of having a baby with heart defects, leading to a 30% overall increased risk of birth defects. Of the 1,248 women who used Zofran in the 1st trimester, 4.7% had a baby with a birth defect compared to 3.5% of women who did not.
Other studies linking Zofran and birth defects include:
- Reproductive Toxicology (December 2014): Swedish study linked Zofran with a 62% increased risk of heart defects, a doubled risk of “hole in the heart” defects, based on data from 1,349 infants exposed to Zofran in the womb.
- Biomed Research International (December 2013): Australian study links Zofran and a non-significant 20% increased risk of birth defects, especially kidney defects, based on data from 251 pregnant women who used Zofran.
- Birth Defects Research (2012): Zofran linked to a 2.4-fold increased risk of cleft palate, based on data from 9,000 pregnant women in Denmark.
There are many ways to help control nausea and vomiting. Eat small and frequent meals, drink plenty of clear fluids, and avoid triggers (such as odors, heat, high-fat foods, etc.). Vitamin B6 and antihistamines can also help — these are the ingredients in Diglegis, a “Pregnancy Classs A” drug that is specifically FDA-approved for pregnant women with morning sickness. Some doctors also prescribe the “Pregnancy Class B” drug Reglan (metroclopramide).
Yes. Over 350 Zofran lawsuits have been filed nationwide as of mid-December 2016. Most of these lawsuits are centralized in a federal Multi-District Litigation (MDL No. 2657) in the U.S. District Court for Massachusetts.
No, and it is unlikely that a Zofran class action will be filed for babies with birth defects. Instead, many victims are filing individual lawsuits and joining the MDL. This has many of the advantages of a class action, like improving efficiency, but each lawsuit remains independent.
No. The first lawsuits were filed in early 2015 and the litigation is still in its early stages. There have been no reports of Zofran settlements being paid to women who had a baby with a birth defect.