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Does Zofran Cause Birth Defects?

Zofran (also called Ondansetron) is a popular morning sickness and anti nausea drug for pregnant women that are manufactured by GlaxoSmithKline. Approved in 1991, the drug was originally approved to treat nausea that was due to cancer treatments or for patients after surgery. Findings suggest that its use may increase the risks of certain birth defects when used by pregnant women. If you have taken Zofran and your child has experienced a birth defect, it is important to get answers. You may have legal recourse against the manufacturers of the drug. You could be entitled to compensation for your medical bills, pain and suffering and loss of income. Speak with a Missouri Zofran lawyer from The Bradley Law Firm for guidance and a free consultation.

What is Zofran?

Zofran is a drug that is known as a 5 HT3 receptor antagonist. It works by adjusting the levels of serotonin in the blood stream, which help to control nausea.

The drug has become quite popular, and can be a welcome relief to a woman suffering from severe morning sickness. Unfortunately however, it appears that the drug can cause a variety of serious birth defects. A study by Dr. Gideon Loren published in late 2014 from the Journal of Obstetrics and Gynecology said that they could not rule out the dangers of taking the drug while pregnant. The study involved 900,000 Danish men and women and found that there was 30% increase of heart defects in babies whose mother took the drug.

In the early years when the drug first came out, the suspicion that Zofran caused birth defects could not be proven. In an early study of 176 women, they found no connection between the drug and birth defects. However it was later argued that the study was flawed and the sample of patients was too small.

After a meeting of the International Society of Pharmacoepidemiology, Danish researchers released evidence from 13 years of research. The study concluded that out of 1,248 women who took Zofran in their first trimester had a baby with a birth defect.

Birth Defects

Taking Zofran during pregnancy appears to be linked to several serious birth defects which include:

  • Atrial septal defects (ASD)
  • Ventricular septal defects (VSD)
  • Hear murmurs
  • Cleft palates
  • Cleft lips
  • Craniosynosis
  • Heart Defects

A study in Reproductive Toxicology published in December of 2014 concluded that Zofran doubled the risk of atrial septal defects (also called “hole in the heart”) When a fetus develops, there are holes in the wall of the heart, which develop into four separate chambers. These holes usually close when the baby is born or shortly thereafter. An atrial septal defect is a hole in the septal wall between the upper left and right chambers. A ventricular septal defect is a hole between the lower left and right chambers. This

This abnormality causes serious circulation problems for the child. Usually oxygen depleted blood enters through the right side of the heart, flows into the lungs for oxygenation, the out the left side through the body. This abnormality can cause:

  • Failure to thrive
  • Heart murmurs
  • Shortness of breath
  • Rapid heart beat
  • Cyanosis
  • Paleness
  • Cleft Palate

The Journal of Birth Defects Research published a study linking Zofran use in the first trimester with a more than double risk of having a child born with a cleft palate. This birth defect occurs when the palate is in the mouth doesn’t close properly during development in the womb. This defect can include not only the palate, but also the teeth, gums and lips.


Generally speaking, this defect appears to be genetic. However environmental factors quickly increase the risk. Smoking cigarettes while pregnant is a good example, and also exposure to toxins and various chemicals can cause the defect.


Unfortunately, children born with this defect will require lengthy medical treatment. Often surgery is required to fix the problem. Once it is repaired, a school age child will need to be continually monitored to watch for speech and hearing problems.


The Department of Justice sued GlaxoSmithKline for unlawful promotion and failure to report the safety of a number of drugs they produce. The company plead guilty to the charges, and was ordered to pay 3 billion dollars in damages in 2012.

Since that time, the incidence of adverse effects from taking the drug continues to rise. If you took this drug while pregnant, it is important to speak with the The Bradley Law Firm to understand what legal options are available to you.