Zofran During Pregnancy: Facts, Myths, and Misinformation

There are many myths, misconceptions, and misinformation about taking Zofran during pregnancy. Pregnant women who suffer from extreme nausea often feel unable to perform even basic daily tasks. Doctors turned to Zofran, a drug that helps control nausea in chemotherapy patients. But GlaxoSmithKline recommended it for off-label use during pregnancy without conducting proper safety tests. As a result, several lawsuits claim Zofran caused birth defects, including congenital heart defects, cleft palate, club foot, and others.

With so many opinions swirling around growing litigation, it’s hard to keep all the facts straight. This infographic should separate fact from fiction so you can make informed decisions about your health—and the health of your baby.

Zofran during pregnancy

From the infographic:


Zofran During Pregnancy: Myths & Misinformation

Zofran anti-nausea medication was approved by the FDA for chemotherapy and radiation side effects. Many physicians also prescribe Zofran off-label to pregnant women with awful morning sickness. But do the benefits outweigh the birth defect risks?

Myth: Zofran is safe to take during pregnancy.

Fact: The use of Zofran has become increasingly popular amongst expecting mothers in recent years. In 2011, the FDA issued an updated warning about using Zofran during pregnancy. The warning stated that Zofran use could lead to severe birth defects.

Myth: Only high doses of Zofran cause birth defects. The amounts doctors prescribe for pregnant women are safe.

Fact: The manufacturer has not tested Zofran in pregnant women, making off-label use unsafe at any dosage amount.

Myth: There’s not any research to show that Zofran use during pregnancy could cause birth defects.

Fact: While taking Zofran during pregnancy can benefit the mother, it can also result in adverse birth defects for the newborn. It is important to know all the facts before deciding to take Zofran. In 2011 a study was published by the Center for Disease Control and Prevention (CDC) stating that Zofran doubles the risks of birth defects.

Myth: If I didn’t use Zofran to treat my severe nausea, I would have lost my child.

Fact: For many women Zofran may seem like the best option to alleviate severe morning sickness while protecting their unborn child, but there is a safer alternative. Doxylamine succinate and pyridoxine hydrochloride (Diclegis) is the only Pregnancy Category A, FDA-approved prescription for morning sickness.

Myth: Zofran is safe to take while breastfeeding.

Fact: According to the FDA, there’s little information on how Zofran affects breast milk. The FDA doesn’t warn against nursing women taking Zofran, but if you do, use caution.

Myth: If a doctor prescribes Zofran, then it must be safe.

Fact: The FDA never approved Zofran specifically for pregnant women. The FDA classifies Zofran as a “Category B” medication. This means animal studies failed to establish any risk to fetuses. However, no sufficient, properly controlled studies can conclusively demonstrate the drug’s safety during pregnancy.

Myth: Zofran use during pregnancy causes all birth defects.

Fact: While it’s true that women who take Zofran during pregnancy may have higher risk of giving birth to a child with a severe birth defect, not all birth defects are caused by the use of Zofran. Current research has only found a correlation between Zofran use and cleft lip/palate, club foot, heart damage/defect, or kidney defect. It’s important to keep in mind that as more research comes to light the Zofran birth defect spectrum may widen.

Myth: Zofran use causes miscarriages.

Fact: As of right now there isn’t any research to support the claim that the use of Zofran can cause a miscarriage. Research on further side effects, including an increased risk of miscarriage still needs to be conducted.

What You Can Do

If you or a loved one had a baby born with birth defects after taking Zofran, you may be eligible for compensation from the manufacturer. Get your free Zofran claim evaluation today and an attorney will contact you shortly to discuss your case.


Jared Heath

Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.