Pregnant women who use Zofran to treat morning sickness in the first trimester may be putting their baby’s health in danger. Recent studies have linked Zofran to a 30% increased risk of birth defects, a doubled risk of heart defects and cleft palate, and other pregnancy risks.

Free Zofran Lawsuit Information: If you or somebody you know had a baby with a birth defect, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.


Zofran (ondansetron) was approved by the FDA in 1991 for the treatment of the most severe nausea imaginable — that associated with chemotherapy. At the time, there was no FDA-approved drug for treating nausea associated with pregnancy. Zofran quickly became a popular “off-label” (unapproved) drug for morning sickness.

Is Zofran Safe to Use During Pregnancy?

Zofran is not approved for use during pregnancy. Yet every year, about 1 million pregnant women use Zofran to treat morning sickness during the first trimester. These women believe Zofran is safe. In reality, Zofran is a “Pregnancy Category B” drug, its fetal safety is unknown (based on fewer than 200 births), and there is growing evidence that it poses life-threatening risks to a developing baby.

Zofran Birth Defects

Our attorneys are investigating potential lawsuits involving:

  • Birth defects
  • Heart defects
  • Heart murmur
  • Atrial septal defect (“hole in the heart”)
  • Cleft lip
  • Cleft palate
  • Fetal growth restriction (poor growth in the womb)
  • Jaundice
  • Kidney defects (hydronephrosis)
  • Life-threatening pregnancy complications
  • Death

Studies Linking Zofran and Birth Defects

  • Zofran was associated with a 2.4-fold increased risk of cleft palate in a study published in Birth Defects Research in 2012, based on data from 9,000 pregnancies.
  • Zofran was linked to a 30% increased risk of major birth defects and a doubled risk of heart defects in a study by Dr. Jon T. Andersen, based on data from 900,000 pregnancies in Denmark between 1997-2010. Out of nearly 1,300 women who used Zofran in the first trimester, 4.7% had a baby with a birth defect.
  • Zofran was associated with a doubled risk of “hole in the heart” defects in a study conducted by Swedish researchers, based on 1,400 pregnancies where it was used in the first trimester.
  • Zofran was associated with to a 20% increased risk of birth defects and even higher rates of kidney defects in a study published by Australian researchers, but the results were imprecise and based on small sample sizes.
  • In June 2014, the Toronto Star published an investigation linking Zofran with 20 reports of birth defects, including heart defects, fetal growth restriction, kidney defects, musculoskeletal abnormalities, fetal death, and more.

What Is the Alternative?

After 30 years without another drug for morning sickness, the FDA approved Diclegis (pyridoxine and doxylamine). Diclegis is a “Pregnancy Category A” drug that combines Vitamin B6 with an antihistamine.

The formula has been used for morning sickness since the 1950s, but was pulled off the market in 1983 over fears of causing birth defects. The FDA re-approved it after studies involving 250,000 pregnancies found no evidence of any risk to a developing baby.

Experts now agree that doctors should change the way they prescribe drugs for morning sickness. According recommendations from Dr. Gideon Koren of the Motherisk Program:

“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.”

Maternal Safety Concerns

Zofran also poses serious risks to a pregnant women. The FDA has issued warnings about heart rhythm disorders, which could be more serious for pregnant women suffering from electrolyte imbalances due to severe nausea and vomiting.

The FDA has also issued warnings about serotonin syndrome, another side effect that could be more serious in pregnant women who are taking SSRI antidepressants.

Moms File 1st Zofran Birth Defect Lawsuits

In February 2015, GSK was hit with two lawsuits from women who took Zofran in the first trimester and had a baby with a birth defect, including:

  • One woman from Minnesota had two children with severe heart defects after she used Zofran during both pregnancies.
  • The other woman, from Massachusetts, had a baby with three heart defects, facial deformities, webbed toes, and a number of other birth defects.

Zofran Lawsuit Settlement

There is no excuse for drug-makers who promote their drugs to pregnant women without warning about the risk of birth defects. In 2012, the maker of Zofran was ordered to pay a $3 billion settlement for illegally marketing several drugs, including Zofran to pregnant women.

Zofran Birth Defect Lawsuit Information

As the number of lawsuits continues to grow, it is possible that they will be consolidated in a mass-tort at the state or federal level — similar to a class action. Instead of a class action, our attorneys are filing individual Zofran lawsuits.

A birth defect is one of the most devastating side effects that any medication can cause. Babies often endure severe pain and suffering, long-term medical treatment, permanent disability, or death. The emotional and financial cost of treatment can be devastating for parents and families.

Our attorneys believe every child who was injured by Zofran deserves compensation and justice. If you decide to file a lawsuit, we may be able to help you recover compensation for your child’s birth defect, past and future medical expenses, your lost income, and more. Call today for more information.

Do I have a Zofran Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Zofran Lawsuit Evaluation: Again, if you or a loved one had a baby with a birth defect, you should contact our law firm immediately. You may be entitled to compensation by filing a Zofran birth defect lawsuit, and our lawyers can help.

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