Checking for a Zofran-related heart defect

Oregon Family Claims Severe Heart Defect Caused By Zofran

On September 11, 2015, parents from Oregon joined more than 60 other families in filing a Zofran lawsuit against GlaxoSmithKline. The couple, parents of a son now 10 years old, says prenatal exposure to the anti-nausea drug caused their child’s rare, severe congenital heart defect.

The family calls Gold Hill, Oregon, a city several hours south of Eugene, home. They filed their complaint in the US District Court for the District of Oregon, Medford Division. It was logged as case number 1:15-cv-01734-CL and a copy can be found below:

View Complaint: 1:15-cv-01734-CL

Did Zofran Cause Son’s Atrioventricular Septal Defect?

Like millions of US mothers, Plaintiff claims she was prescribed Zofran after suffering from nausea and vomiting in the first trimester of pregnancy. Notably, her pregnancy began in late-2004, which should give many parents who are now raising adolescents with heart defects hope that filing a Zofran lawsuit is still possible.

In their complaint, the parents say their son M.K. was born on September 16, 2005. In the following days, a pediatrician would hear a “heart murmur,” they claim, an abnormal sound usually caused by congenital heart defects.

Heart Murmurs

Often likened to a “whooshing” sound, heart murmurs are a sign of turbulent blood flow through the heart. The sounds can be extremely specific; depending on their volume and direction, cardiologists can often diagnose conditions associated with heart defects, like pulmonary hypertension.

Heart murmurs aren’t loud enough to hear with the ear alone; doctors use stethoscopes to catch them.

Shortly after, M.K. was diagnosed with an atrioventricular septal defect, a hole at his heart’s center. In healthy human hearts, each of the organ’s four chambers are separated from the others by a complete wall. These four walls meet near the center of the heart.

But for M.K., and around 2,000 other American babies every year, blood is allowed to flow unregulated between the chambers. This drastically reduces the total amount of oxygen that is allowed to reach organs and tissues within the body, and normally constitutes a crisis situation.

Zofran and heart defects diagram

In this diagram from the CDC, we can see how a typical atrioventricular septal defect allows blood to flow directly from the heart’s left side to its right.

According to court documents, M.K. underwent open-heart surgery at only five months old, but his atrioventricular septal defect remains “unresolved.” He continues to frequent heart specialists, who say he may require further procedures in the coming years. Meanwhile, his defect has “limited […] his ability to engage in various normal childhood activities.”

Zofran And Heart Defects: What Does Science Say?

Two large European studies have linked the anti-nausea drug Zofran to “cardiac septal defects,” a class of heart abnormalities that includes atrial septal defect, ventricular septal defect and atrioventricular septal defect.

Zofran seems to increase the risk of developing these defects in babies exposed to the drug before birth. But the most acute risk appears to lie in relation to atrioventricular septal defects, an extremely severe form of “hole in the heart.” In one study performed in Denmark, mothers who ingested Zofran in the first trimester were almost 5 times more likely to have babies with an atrioventricular septal defect.

Since 2012, at least three studies have found an association between Zofran and increased birth defect risks. But none are mentioned on the drug’s warning label, and GlaxoSmithKline has never addressed the potential link publicly. Plaintiffs call this a great injustice, saying the company has a duty and obligation to inform the public, pregnant women and health community of its product’s risks.