What if the most popular drug used to treat morning sickness was not approved by the Food and Drug Administration (FDA) for morning sickness? What if a large study found that babies of moms who took the drug during the first trimester had double the risk of being born with a heart defect? That would be scary. Right?
Well, it’s all true. The drug is called Zofran and it is the most commonly prescribed drug for morning sickness. About one out of four women get a prescription during their first trimester. Some studies do suggest an increased risk for heart defects. [1,2]
If you have taken the drug, do not Google it! You will find pages and pages of law firms looking for clients. You will panic. You don’t need to panic. Let’s take a deep breath and look at the facts.
Morning sickness occurs in about 80 percent of pregnant women. In most cases it is not severe enough to cause concern. But for some women, severe morning sickness can lead to dehydration and weight loss that can be dangerous for a pregnancy. [1,2]
Zofran is the brand name for ondansetron, a drug that was developed to treat nausea and vomiting caused by cancer treatment or surgery. It works well, so it is used off-label for severe morning sickness in pregnancy. [1,2]
Off-label use is common for many drugs. But morning sickness occurs early in pregnancy when birth defects are most likely to occur.  So when some studies started to link Zofran to birth defects, phones start to ring in doctors and lawyers offices.
What the Studies Show
Over the last 15 years, data has been accumulating on Zofran during pregnancy. The results are, at best, murky. Here is an overview: 
- An Australian study compared 251 pregnant women who took Zofran to a large group of women who did not. The study took data from 2002 to 2005. They found a 20 percent increase for major birth defects in the Zofran babies.
- A larger Danish study compared 1,970 pregnant women who took Zofran to a large group of women who did not. The study took data from 2004 to 2011. They found no increased risks for the Zofran women.
- Another Danish study compared 1,248 pregnant women who took Zofran to a large group who did not. The study took data from 1997 to 2010. They found a doubled risk for babies with heart defects in the Zofran group compared to the other group.
- In two smaller studies, a Canadian and Australian study of 176 women who took Zofran found no increased risks for any birth defects compared to the same number of women who did not take Zofran. An Australian study of 55 women who took Zofran found an increase risk for babies with cleft palate. The odds were 2.4 times higher for these babies than for babies of a larger group of women who did not take Zofran.
What to Do?
If you took Zofran, odds are very good that your baby will be fine. But the weight of the evidence suggests avoiding Zofran if possible. Luckily there are safer alternatives for morning sickness. [1,2]
In 2013, the FDA approved a drug called Diclegis for morning sickness. This drug is a combination of vitamin B6 and an antihistamine.  It is a safer alternative. Other options for morning sickness include: [1,4]
- Don’t jump out of bed in the morning with an empty stomach. Lie in bed for a while and eat a few crackers.
- Eat smaller meals more frequently throughout the day and drink plenty of fluids.
- Avoid foods that make you feel queasy.
- Avoid fatty and spicy foods.
- Try taking some ginger if you feel nauseous.
- Try a Peggie Pop. This product is a lollipop that contains ginger, mint, lavender, and a sour fruit.
So there you go. No need to panic, but no need to take Zofran unless you have tried everything else first. Talk to your doctor if you need help with morning sickness. Getting weak and dehydrated is not good for your pregnancy and there are plenty of safe options that can help.
Have you tried this before? Share your thoughts with us in the comments section below.
You may also want to read the following related posts in Pregistry’s blog: Hyperemesis Gravidarum – Between a Rock and a Hard Place, 15 Facts You Should Know about Nausea and Vomiting during Pregnancy, and 15 Strategies You Should Know for Dealing with Nausea and Vomiting During Pregnancy.
- UT Southwestern Medical center, Zofran for morning sickness: The risks are minimal.
- Medscape, Ondansetron in Pregnancy.
- FDA, News Release.
- American Pregnancy Association, Morning Sickness relief: Treatment & Supplements.