As referenced in our About Zofran section, Zofran was manufactured by GSK as a drug intended to treat the most severe vomiting and nausea caused by radiation and chemotherapy. The FDA approved it for this purpose in 1991. Going beyond what the FDA approved for usage, GSK promoted Zofran “off-label” as a drug for alleviating morning sickness in pregnancies. Over the years doctors prescribed Zofran and mothers-to-be took Zofran during the most crucial developmental stages of a pregnancy for the fetus, the first trimester. Now, studies have shown that one of the many birth defects associated with taking Zofran during pregnancy could be a congenital heart defect. This defect has been reported to include babies born with:
- Atrial Septal Defect (ASD);
- Ventricular Septal Defect (VSD); and
- Heart Murmur
Other defects include cleft lip and cleft palate.
The Link Between Zofran / Ondansetron and Atrial Septal Defect, Ventricular Septal Defect, and Heart Murmurs
Below are some of the epidemiological studies performed around the world and their findings with respect to the increased risk of child birth defects as they pertain to congenital heart defects.
The Pasternak Study
In this study, there was a finding that mothers who ingested Ondansetron during the first trimester had a 41% increased risk in a their newborn having a VSD. This study was performed in Denmark on over 600,000 pregnancies. Read more here.
The Andersen Study
As a follow up study to the Pasternak study, the Andersen Study reviewed over 900,000 births in Denmark. They concluded that Zofran increased the risk of a septal cardiac defect by 2 to 4 times, and also noted a 30% increase in the risk of malformations. Read more here.
The Danielsson Study
Another more recent study looked at Swedish births from 1998 to 2012 and found that the risk of a baby being born with a hole in the heart was doubled, and the risk of another cardiovascular defect increased by 62% after the mother ingested Ondansetron during the first trimester of pregnancy. Read more here.
In June 2014, The Toronto Star reported that in their own investigation into Ondansetron / Zofran and the increased incidence of child birth defects, they found medical records which showed that in one case a doctors suspected the drug caused a heart murmur and atrial septal defect, also known as hole in the heart.
What is Atrial Septal Defect / Hole In The Heart?
ASD or “Hole in the Heart” is a very common child birth defect where there is a hole in the wall of the two upper chambers of the heart. The hole is usually as a result of a malformation of the tissues during development of the fetus, thus making it a “congenital” heart defect. A small defect, of less than 5mm, is likely to heal itself and cause no long-term issues. However large atrial septal defects can have very serious long-term health consequences. Typically ASD is more common in girls than in boys.
What Complications Are Caused By ASD?
At child birth, a large ASD can result in low oxygen levels in the blood causing the child to be blue. In the few weeks after birth, the baby will also exhibit lethargy, weakness, and developmental delays. The main reason for this is that ASD greatly effects the oxygenating process of the blood. The hole in the chamber walls allows oxygenated blood to flow to the chamber which sends poorly oxygenated blood to the lungs. This will cause a “swishing” sound, also known as a heart murmur.
Here is a list of common symptoms:
- lung infections
- poor growth and developmental delays
- poor appetite
- shortness of breath
- abnormal heart rhythm
- high blood pressure / pulmonary hypertension
What Causes ASD?
Many doctors are unclear as to the direct causes of ASD. Studies have shown that in many cases the development is genetic. However, again many different drugs have been linked to increasing the risk of ASD since these drugs are taken in the most crucial developmental time of the fetus. Zofran, has been strongly linked to increase the likelihood of an atrial septal defect as seen above. Zofran must have been ingested by the mother in the first trimester in order for it to have been a contributing factor or even the sole cause of the ASD. For more information on Zofran studies click here, and to see more information on GlaxoSmithKline’s knowledge about these risks click here.
What Are The Procedures For Repairing ASD?
A small ASD will usually close on its own, requiring no additional procedures. A large ASD may require open heart surgery. The treatment plan for ASD will vary depending on when the diagnosis occurred in the child’s lifetime. An ASD can be difficult to diagnose as the murmur is more difficult to hear versus other heart defects such as Ventricular Septal Defects.
A cardiac catheterization is a common procedure to repair the hole in the heart. This procedure involves a tube positioning an implant in the hole to seal the ASD. This procedure is preferred since there is no scarring, and the implant is fused over time with tissue growing over the implant. This procedure is common with a short recovery time and an overnight stay in hospital in most cases.
An open heart surgery is a much more serious operation where a surgeon will open the chest and stitch or seal the hole with surgical material. Again, 6 months after the operation, the hole will be completely sealed by the material and tissue that has grown over the repair.
In terms of long-term effects, the child may suffer some blood clotting, however aspirin is typically prescribed in the first 6 months to alleviate this condition. In addition, the child will take antibiotics for 6 months to avoid the development of infective endocarditis. After the six month period expires, this condition is no longer a concern. The younger the child is when the surgeries are performed, the less pain and suffering they will experience and recovery is quick.
What is Ventricular Septal Defect or VSD?
Instead of the hole in the heart being in the upper chamber walls, a VSD is where the hole occurs in the dividing wall between the ventricle chambers, which pump blood around the body. A VSD is the most common form of a congenital heart defect. Like the ASD, the VSD also allows oxygen rich blood to transfer from each chamber increasing the pressure on the heart and lungs, and causes congestion.
What Causes VSD?
Like ASD, VSD’s cause is not known fully by the medical community. Again, studies have linked one cause of VSD to be the ingestion of Ondansetron during the first trimester of pregnancy in order to alleviate morning sickness. Doctors also believe that VSD can be genetically caused.
What Complications Are Caused by VSD?
Where the VSD is small, there is relatively little impact on the child and the hole usually repairs itself quickly. Where the VSD is large, the child will experience the following:
- shortness of breath
- trouble feeding
- developmental growth issues due to lack of nurishment
- high blood pressure
VSD can be diagnosed early by listening for a heart murmur caused by the swishing of blood as it is pumped to the lungs with more oxygen than is normal. If not detected early, a VSD can be fatal as it leads to increased blood pressure and developmental delays that can lead to heart failure.
What Are The Procedures For Repairing VSD?
The procedures to repair a VSD are the same as those outlined above for an ASD. The future risks to your child include aortic leak, so regular heart checkups become routine because of this condition. Endocarditis is another risk that needs to be watched after repair of a VSD.
Do I Have A Zofran Lawsuit If My Child Was Diagnosed With A Congenital Heart Condition Such As ASD Or VSD?
From reviewing the above information about the links between Zofran and child birth defects such as ASD and VSD, and the first Zofran lawsuit being filed against GSK, you may be wondering if your family has a lawsuit? You likely have many other questions, so we encourage you to review our FAQs on Zofran Lawsuits.
The best way to determine if you have a viable cause of action against the manufacturer of Zofran is by speaking with our experienced mass torts lawyers. The call and consultation is free. Our compassionate lawyer will evaluate your specific facts and determine if you have a case. If you took Zofran during the first trimester of your pregnancy and your child was born with a heart defect such as ASD or VSD call us 24/7 toll-free on (877) 620-8411.