Zofran Birth Defects

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Did you get a prescription for Zofran during pregnancy? Did your child suffer congenital birth defects or prenatal problems? You may qualify to file a Zofran birth defect lawsuit because of the complications suffered by your child. The risks of taking the medication while pregnant may not have been fully made clear. Your child’s suffering may be because of taking the medication while pregnant.

Zofran supposedly treats morning sickness during pregnancy, yet this birth defect risk is not on the drug’s warning label. This has led to Zofran lawsuits accusing the drug maker of illegally marketing Zofran for morning sickness.

Several Zofran lawsuits have been filed alleging that a child was born with birth defects as the result of prenatal exposure to Zofran, according to court documents.

Zofran birth defects mentioned in lawsuits include:

  • Heart defects, including septal defects (holes in the heart)
  • Cleft lip
  • Cleft palate
  • Club foot
  • Craniosynostosis (skull deformities)
  • Kidney defects
  • Poor fetal growth
  • Fetal death (related to birth defect)

If you or a member of your family had a birth defect after the mother took Zofran during her pregnancy, you can share the details and get a case evaluation at no charge. You may have entitlement to significant compensation.


In 2012, GlaxoSmithKline, entered into settlement negotiations with the U.S. Department of Justice for illegal marketing practices of pharmaceutical drugs, including marketing used for Zofran for use with pregnant women, according to court documents (U.S. District Court of Massachusetts, LeClair v. GlaxoSmithKline LLC, Case 1:15-cv-10429).

Taken prenatally, Zofran has allegedly led to infant defects and side effects damaging to the baby. Patients prescribed the medication was not aware of the risks. So, Zofran patients may qualify for significant settlement compensation if the claims are found to have merit in court or if a settlement is reached.

The current claim filed alleges GlaxoSmithKline marketed the drug to pregnant women without FDA approval. Originally approved to help cancer patients with nausea and side effects of chemotherapy such as vomiting, GSK expanded marketing to include pregnant women suffering morning sickness—a move with no approval by the FDA.


A number of studies have raised concern that taking Zofran while pregnant increases the risk of birth defects, especially when used during the first trimester. Unfortunately, this is often when morning sickness during pregnancy is at its worst, which means women are more likely to be prescribed Zofran during this risky time period.

Due to the Zofran pregnancy category B, Zofran is often prescribed to treat morning sickness despite the fact that the safety of taking Zofran while pregnant has not been well studied.

In 2013, a Danish study involving 600,000 births found there was no significant risk of Zofran birth defects. However, six months later, another study based on 900,000 births from the same registry found a 30 percent increased risk of Zofran birth defects overall, and a doubled risk of heart defects.

Other alarming Zofran pregnancy research includes:

  • In 2012, a Zofran study from the Center for National Birth Defects Research and Prevention identified a 2.4-fold increased risk for cleft palate and cleft lip when Zofran was used during the first trimester to treat morning sickness.
  • A 2014 investigation by the Toronto Star found at least 20 Canadian women had reported serious Zofran side effects to the Food and Drug Administration (FDA) after being prescribed Zofran for morning sickness, including two infant deaths and multiple cases of Zofran birth defects of the heart and kidneys.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”


Zofran users file birth defect lawsuits with claims the medication posed an unreasonable risk to the health of the babies carried.

If you or a loved one had a child with birth defects, you may have entitlement to compensation.

In 2012, Time Magazine listed attorney McDonald Worley among the leading trial lawyers in the nation. Find out what your legal options are from one of the Nation’s best Zofran lawyers today.