Zofran Linked to Septal Defects, Risk of Other Heart Problems

Studies have found that use of Zofran early in pregnancy may increase the risk that babies will suffer congenital heart defects or other health problems.

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Although GlaxoSmithKline knew or should have known about the potential Zofran heart risks for the fetus, inadequate warnings were provided to women and the medical community about use of the anti-nausea drug during the first trimester of pregnancy.

The lawyers at Saiontz & Kirk, P.A. are pursuing cases for families throughout the United States who may be entitled to financial compensation through a Zofran heart defects lawsuit.

Request a free consultation and case evaluation if your child has suffered any of the following heart problems following Zofran exposure while pregnant:

  • Atrial Septal Defect (ASD)
  • Ventricular Septal Defect (VSD)
  • Atrioventricular Septal Defect (AVSD)
  • Patent Ductus Arteriosis (PDA)
  • Patent Foramen Ovale (PFO)
  • Heart Murmur or Palpatations
  • Holes in the Heart, Enlarged Heart (Cardiomegaly) or Other Cardiac Malformation
  • Congenital Heart Disease, Heart Failure or Other Heart Defects

All lawsuits are handled by our Zofran injury lawyers on a contingency fee basis, which means there are no out-of-pocket expenses to pursue a case, and we only receive an attorney fee or expenses if a recovery is obtained for your child. Find out if your family may be entitled to pursue a Zofran heart defect case.

Zofran Heart Problems

Zofran, known generically as ondansetron, is a prescription medication sold by GlaxoSmithKline, which is approved to treat nausea and vomiting following chemotherapy, radiation treatment or surgery. However, it has been widely marketed and prescribed “off-label” for use among pregnant women to treat morning sickness and hyperemesis gravidarum (HG) pregnancy.

Although information has been known about the potential heart defects risk from Zofran use in pregnancy, GlaxoSmithKline failed to provide adequate warnings to doctors and women about the side effects their babies may suffer if the medication is used during the first trimester.

Several studies have found that Zofran may cross the placenta, potentially exposing a fetus to high levels of the drug during a critical developmental period for the heart and other internal organs.

This may cause babies to face a risk of several different congenital defects or cardiac problems that will impact the child for the rest of their life.

In August 2013, Danish researchers presented a study (PDF) that highlights the potential Zofran heart side effects for babies exposed to the medication early in pregnancy.

The study involved a review of data on more than 900,000 births from the Danish Medical Birth Registry, including 1,368 women who received a prescription for Zofran in the first trimester.

Researchers concluded that there is an increase in the prevalence of major congenital heart defects following Zofran use during the first trimester, including a:

  • 30% Increased Risk of Congenital Malformations;
  • 1.6 Times Risk of Heart Defects with Zofran;
  • 2.1 Times Risk of Atrial Septal Defects or ASD;
  • 2.3 Times Risk of Ventricular Septal Defects or VSD; and
  • 4.8 Times Risk of Atrioventricular Septal Defect or AVSD.

An October 2014 study published by the medical journal Reproductive Toxicology provides further support for the findings, concluding that there is a statistically significant elevated risk of cardiovascular defects among infants exposed to Zofran early in pregnancy.

Babies born to mothers prescribed Zofran had a 62% increased risk of suffer a heart defect, with a 2 fold increased risk of a septal cardiac defect, which involves holes in the heart from Zofran.

Zofran Septal Heart Defects in Newborns

Some of the more common heart problems associated with Zofran include:

Atrial Septal Defects (ASD): This congenital cardiac defect may result if Zofran causes a hole in the heart during formation early in pregnancy. This involves a hole in the wall that separates the two top chambers, allowing oxygenated blood to leak into the oxygen poor parts of the heart, forcing the heart and lungs to work harder, which can lead to damage to the arteries.

Ventricular Septal Defects (VSD): This is a variety of cardiac defect involving a hole in the lower chamber of the heart. It can cause the heart to have an under-developed left side, or result in the heart missing a pulmonary valve and other malformations. These generally cause blood flow problems or prevents blood from taking its natural course through the body, resulting in a lack of oxygen dissemination.

Atrioventricular Septal Defect (AVSD): Also known as a “common atrioventricular canal” or “endocardial cushion defect”, this condition involves problems with the septum of the heart between the right atrium and left ventricle. This may result in difficulty breathing, irregular heartbeat or other signs of heart failure.

Aortic Valve Stenosis (AVS): This is a defect that results in a heart valve not opening and closing properly. It can also lead to the heart leaking blood or trapping blood in the heart, resulting in a buildup of pressure that causes damage.

Heart Murmur: Babies diagnosed with a heart murmur following Zofran use may be exhibiting signs or symptoms of a heart defect. While some heart murmurs or heart palpitations may not be a sign of more serious cardiac problems, this may be a first sign of a septal defect from Zofran.

Other Zofran Heart Risks

In addition to causing heart defects for unborn babies, side effects of Zofran may also cause heart rhythm problems for users of the medication, known as QT prolongation.

In June 2012, the FDA warned that Zofran may impact the electrical activity of the heart, which can cause QT prolongation and lead to patients developing Torsades de Points, a rare variety of ventricular tachycardia which can be fatal if not properly treated.

The FDA forced GlaxoSmithKline to update the drug’s label at that time and ordered the company to conduct additional studies. However, the drug had been on the market for years and it appears the company failed to conduct proper clinical trials to detect the side effect risks, or knew and failed to adequately warn the medical community.

Lawsuits Over Zofran Cardiac Defects

GlaxoSmithKline placed their desire for profits before the health and safety of children by recklessly and illegally marketing Zofran for use during pregnancy, even though the FDA has never approved the medication for morning sickness or determined that it is safe for the hearts of infants.

Rather than studying and evaluating the potential heart side effects Zofran may cause for the fetus, the manufacturer encouraged off-label use of the medication among pregnant women, hoping to capitalize on the millions of women who experience nausea and vomiting in pregnancy.

If proper warnings had been provided, women and doctors may have chosen not to use of Zofran during the first trimester and many children born with heart defects may have avoided serious cardiac complications.

To find out whether your child may be entitled to financial compensation, contact our Zofran heart defect lawyers to review what legal options may be available.