Zofran Lawsuits – What You Need to Know

If you suspect that taking Zofran (generic name: ondansetron) to treat morning sickness caused your child to have birth defects, the time to act is now. Not only will a settlement help alleviate the impact of medical expenses required for the caring of your affected child, it also sends a message to pharmaceutical companies such as GlaxoSmithKline (GSK), the creators of Zofran, as well as to the doctors who chose to prescribe Zofran without warning mothers of the risks, that this sort of negligence is not okay.
Zofran – You’re not alone

Nausea or vomiting during pregnancy (NVP), commonly referred to as morning sickness, occurs in 80% of pregnancies. In its most serious form, NVP can lead to hyperemesis gravidarum, a condition characterized by extreme nausea and vomiting that can cause malnutrition, placing the lives of the mother and fetus at risk. NVP often requires hospitalization.
With this in mind, it’s not surprising to find that approximately 10-15% of pregnant women use medications to treat morning sickness. In fact, according to a recent article in the American Journal of Obstetrics & Gynecology (AJOG), “about 1 million pregnant American women are exposed to ondansetron out of 4 million pregnancies a year.” Some recent reports show that using Zofran increase the risk of having a child with birth defects by 30%. That’s a high risk in a large number of pregnancies.

Zofran and birth defects

Because morning sickness most often occurs during the first trimester, the pregnant mother is taking Zofran at the infant’s most critical and fragile stage of development. Birth defects commonly linked to Zofran include the following:

Cleft lip

Cleft palate

Heart problems such as septal defects (holes in the heart)

Kidney malformations

Club foot

Craniosynostosis: a condition characterized by an abnormally shaped skull that sometimes may not leave enough space for the brain, leading to mental impairment and vision problems


Fetal death

Why is GSK negligent?

Treatment of anti-nausea associated with surgery and chemotherapy are the only uses for Zofran, and its generic counterpart, that have been approved by the U.S. Food and Drug Administration (FDA). Yet GSK has been promoting Zofran (as well as other drugs) for off-label uses such as morning sickness for a long time. In 2012, GSK readily admitting their culpability, agreeing to pay $3-billion to settle claims with the U.S. Department of Justice regarding the drug.

An approved solution for morning sickness

According to AJOG, pregnant women now have a viable alternative to taking non-tested drugs for morning sickness. In 2013, the FDA approved using a combination of doxylamine and pyridoxine to treat nausea and vomiting in pregnant women. “Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety,” the article stated.
Have you or a loved one suffered from birth defects that may have been caused by Zofran? If so, call one of our experienced pharmaceutical drug attorneys at 1-888-728-9866 for a free consultation.