Zofran & Pregnancy: All You Need to Know

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The side effects of taking Zofran in pregnancy is generally low. Doctors have prescribed Zofran for years to treat pregnancy nausea. However, moms around the United States worry if Zofran can actually harm pregnancy and cause birth defects.

Zofran-and-Pregnancy
Does Zofran increase the risk of heart defects and orofacial malformations?

Pregnant moms know morning sickness too well. The awful feeling of nausea in the first few weeks of pregnancy makes you want to crawl in bed, have saltine crackers, ginger tea, and take a nap.

But responsibility and work drag your feet out of your comfy and fluffy bed. Sadly, even pregnancy can’t stop that. Life must go on. 

So, you called your doctor and they prescribed you Zofran to ease your struggle with nausea. But, hours of reading on the internet and mom’s forum about Zofran and pregnancy makes you uneasy.

Didn’t they say that Zofran causes birth defects? That one mom clearly said she regretted taking Zofran while pregnant, why?

To ease your problem (because that’s what this blog does) I have gathered information around the Internet and collected them into one big post. 

I hope this can help you know what people experienced about Zofran and the effects on their pregnancies.

What is Zofran?

Zofran (ondansetron) is an oral medicine used to treat nausea and reduce vomiting in patients with cancer caused by surgery, chemotherapy, or radiation therapy.

It blocks the actions of chemicals in your body that trigger nausea and vomiting, hence preventing you from feeling nauseated.

Drugs.com mentioned Zofran side effects as following;

  • Blurred vision
  • Temporary vision loss (lasting from only a few minutes to several hours)
  • Slow heart rate
  • Trouble breathing
  • Anxiety
  • Agitation
  • Shivering
  • Feeling like you might pass out
  • Urinating less than usual or not at all

Drugs.com recommends you to stop taking Zofran and call your doctor immediately if you experience any of those side effects.

Zofran may impair your thinking or reactions. Therefore, be careful if you have to drive or operating any heavy machinery.

I Took Zofran While Pregnant. Is It Safe?

Originally, doctors use Zofran to treat nausea in patients with cancer during chemo, and Zofran is not expected to harm an unborn baby. Doctors have prescribed Zofran for years to treat nausea in pregnant mothers. 

Gladly, someone took this matter seriously. In August 2018, Slone Epidemiology Center at Boston University with the CDC did this research that explains if Zofran causes birth defects in pregnancy.

Now, to answer your question, “I took Zofran while pregnant, is it safe?”

The answer is yes.

In 2014, around 22% of pregnant women in the United States used Zofran at some point during their pregnancy. 

Harvard-affiliated Brigham and Women’s Hospital (BWH) conducted a study involving 88,000 pregnancy cases where pregnant women took ondansetron during the first trimester.

In a paper published online in JAMA, the team reports no increased risk of heart defects and a very small increased risk of oral clefts. The team found an adjusted relative risk for heart defects of 0.99 with tight confidence intervals (0.93 – 1.06). 

Orofacial malformations (clefts)Cardiac malformations (heart defects)
Exposed to ondansetron (Zofran)14 cases per 10,000 births94.4 per 10,000 births
Unexposed to ondansetron11.1 cases per 10,000 births84.4 per 10,000 births
Source: An article published in The Harvard Gazette

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It is strong evidence that there is no difference in risk for heart defects whether you consume Zofran.

The researchers say that the results suggest ondansetron doesn’t meaningfully increase the risk of congenital malformations, although a small increase in the risk of oral clefts cannot be excluded.

In conclusion, the research suggested that taking Zofran during early pregnancy did not appear to increase the chance of having a baby with a birth defect. Although, the medical community recognizes a small existent risk.

How Safe Is Zofran for the First Trimester?

Healthline mentions the risk of taking Zofran while pregnant is low. The general consensus is that Zofran is relatively safe to take in all trimesters during pregnancy.

According to the CDC and the 2018 study, researchers found about 7 in 10 mothers experienced morning sickness during the first trimester of pregnancy.

Before 2000, about 1 in 100 pregnant moms were prescribed Zofran. Because it didn’t seem to give any visible side effects, doctors prescribed it more often. By 2011, about 1 in 10 pregnant moms use ondansetron to treat nausea.

It means doctors have prescribed Zofran for pregnant moms for about 10 years. 

Birth defects are common and critical conditions that affect 1 every 33 babies born in the United States. Although, taking Zofran during early pregnancy did not appear to increase the chance of having a baby with a birth defect. 

Healthline mentions one meta-analysis of eight studies that suggested taking Zofran in the first trimester could cause a very small increase in the risk of heart defects and orofacial cleft.

The FDA agrees with the CDC saying that the data don’t make a reliable correlation between Zofran and the increased risks of birth defects.

Having said that, the CDC suggests pregnant moms should discuss options for treating morning sickness during pregnancy with their healthcare providers.

Doctors Prescribe Less and Less Zofran

Some claims around the internet that mentions the Zofran lawsuits or says that Zofran causes a huge increase in birth defects risks are not traceable. 

The one I found was a story of a mom with triplets who took Zofran before the first 8 weeks of pregnancy. One of her sons is born with a heart defect that requires surgery.

However, she is not convinced that Zofran causes a heart defect in her son. She mentioned it could be from the ginger beer she consumed a lot to reduce morning sickness symptoms, or the genetics in the family because one grandparent had a cardiac defect that also required surgery.

The research in 2012 suggested that possible risks of birth defects related to proton pump inhibitors (PPIs), steroids, and ondansetron like Zofran. But further research is needed to find the exact correlation between Zofran and an increased risk of birth defects.

The meta-analysis suggested that Zofran does increase the risk of heart defects or orofacial cleft, but the reported increase in risk was small.

If you take Zofran while being pregnant, the risk of birth defects increased by 0.03% for orofacial malformation like cleft palate and 0.03% for heart defects.

But nowadays, doctors prescribe less and less Zofran due to the possible liability risk since the FDA approved a new medication for morning sickness called Bonjesta.

The Bottom Line

Zofran (ondansetron) is mostly safe to take during pregnancy with only a small risk of orofacial malformations and heart defects. However, the risks seem to be higher in the first trimester.

The FDA has approved a new medicine to treat nausea in pregnant women called Bonjesta, and doctors have prescribed less and less Zofran in 2020. 

This post is informational and does not suggest you to take or not to take any medicine. Discuss your morning sickness symptoms with your healthcare providers.

Zofran & Pregnancy Infographic
Zofran & Pregnancy Infographic

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Elise Schiller
Elise Schillerhttps://www.parenting-hub.com
Elise is the head writer in Parenting Hub. She focuses on early childhood parenting and teenage years. Currently, she also learns about parenting adult children. She enjoys writing and sharing insights regarding child development and mental health.

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