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Heart abnormalities and congenital heart defects are among the many types of birth defects associated with Zofran (also known as Zuplenz or ondansetron) use by pregnant women. Zofran has never been approved for morning sickness treatment, yet doctors all across North America are prescribing the medication for pregnant women with nausea and vomiting.

The following disorders are the types of infant heart abnormalities associated with Zofran use:

Ventricular Septal Defect

Ventricular Septal Defect  (VSD) occurs when a hole forms in the wall between the lower chambers of the heart. When VSD develops, an infant’s oxygen-rich blood passes through the hole and into the left ventricle, causing the heart to overwork.

If VSD isn’t treated, the infant may develop a lung disease and high blood pressure.
checking baby’s heart

Atrial Septal Defect 

An atrial septal defect (ASD) is similar to VSD in that it causes a hole in the wall of the heart. However, if an infant develops ASD, the hole occurs in the heart’s two upper chambers.

ASD causes blood to overfill the lungs, which makes the heart work faster. Consequently, the heart can grow larger than normal and eventually weaken.

Heart Murmurs

Heart murmurs are abnormal sounds when the heart beats. Heart murmurs range from mild (barely audible) to severe. Symptoms may include difficulties in breathing, failure to thrive adequately, blue lips, chest pains, and difficulties with feedings.

In severe cases of heart murmurs, infants may need a series of treatments, including medications, beta blockers, and in extreme instances, open heart surgery or valve replacement.


Cardiomyopathy is a serious, life-threatening heart defect that can require a total heart replacement in the most severe cases. Cardiomyopathy is marked by an enlarged, thickened heart muscle. In turn, the heart becomes weaker over time, which may lead to complete heart failure.

Pulmonary Atresia

Pulmonary atresia is a congenital heart defect marked by the pulmonary valve failing to open properly.

Tetralogy of Fallot

Tetralogy of Fallot is a congenital heart birth defect, marked by four different medical conditions, which include:

  • Right Ventricular Hypertrophy
  • Overriding Aorta
  • Ventricular Septal Defect
  • Pulmonary Stenosis

Aortic Valve Insufficiency

Aortic valve insufficiency, also known as pediatric Aortic valve insufficiency and aortic regurgitation, is a medical condition that occurs when blood from the left ventricle is forced into the ascending aorta and then back into the left ventricle. It occurs because the aortic valve doesn’t completely close as it should, which, in some cases,  can be life-threatening.

Bicuspid Aortic Valve 

A bicuspid aortic valve is a congenital birth defect that occurs when the aortic valve, which usually has three leaflets, develops with only two leaflets. It forms early in pregnancy, during the first trimester, right around the time that an infant’s heart starts to develop, and during times when pregnant women typically take Zofran the most.

Treatment for Infant Heart Defects and Abnormalities

Treatment for heart defects and abnormalities will greatly depend upon not only the type of heart condition the baby has, but also the severity. In mild cases, sometimes no treatment at all is necessary.

For more severe cases, however, the infant may require special medications, surgical procedures, respiratory therapy, and even an open heart transplant. If you have any questions regarding the treatment your infant’s physician suggest, make sure to ask any pertinent questions beforehand. If you feel uncomfortable with treatment options, don’t hesitate in getting a second medical opinion if you feel that it is needed.

Zofran Studies on Heart Abnormalities

In 2013, a study performed on 900,00 pregnant women who took Zofran had a “2-fold increased risk of cardiac malformations with Zofran, leading to an overall 30 percent increased risk of major congenital malformations.”

Another study performed by Dr. Gideon Koren indicates that pregnant women who take ondansetron are at a heightened risk of having infants with heart abnormalities, and numerous other birth defects.

Although additional studies conflicted with Dr. Koren’s results on Zofran, many women have had babies with severe heart abnormalities after taking Zofran while pregnant.

For example, in 2013, Kylee Reisen, of North Dakota, was prescribed Zofran in her first trimester of pregnancy, gave birth to a daughter with a severe congenital heart defect. Her daughter, now 2-years-old, had to undergo major open heart surgery to repair numerous holes in her heart.

Unfortunately, Reisen’s story is just one of the numerous cases of infants being born with serious, life-threatening birth defects after being exposed to Zofran.

What To Do if Your Baby Has Heart Abnormalities

If you were prescribed Zofran while pregnant and your infant was born with a birth defect, you may be eligible for considerable compensation for medical bills, pain, suffering, and more.

Medically, your baby may need to undergo extensive treatment, depending on the severity of the birth defect. It’s important to seek medical attention right away, as some heart abnormalities need prompt treatment for the chances of recovery.

Legally, you can file a claim against GlaxoKlineSmith (GSK), the manufacturers of the medication that pushed doctors to prescribe Zofran for off-label use for morning sickness. As more and more families learn of the harmful risks of taking Zofran while pregnant, lawsuits continue to pile up against GSK, who allegedly failed to warn the public of the hazards of taking the medication during pregnancy.