Zofran has been linked to a heightened risk of certain birth defects if taken during pregnancy. One of the most severe types of birth defects are heart malformations, including a bicuspid aortic valve, also known as bicommissural aortic valve or bicuspid aortic valve disease (BAVD).
What is a Bicuspid Aortic Valve?
A bicuspid aortic valve is a congenital birth defect in which an aortic valve, which usually has three leaflets, has only two. An aortic valve is responsible for regulating the blood flow from the aorta into the heart. The aortic valve also stops blood from going back into the heart after the chamber relaxes.
A bicuspid aortic valve forms early in pregnancy, during the first trimester, right around the time that an infant’s heart starts to develop.
Bicuspid Aortic Valve Symptoms
Usually, other heart defects lead to the discovery of a bicuspid aortic valve as is infants do not always exhibit symptoms. However, other symptoms that may lead to diagnosing bicuspid aortic valve include:
- Chest pain
- Difficulties with breathing
- Heart palpitations
- Pale-colored skin
- Weakened pulse in the ankles and/or wrists
- Enlarged heart
Diagnosing Bicuspid Aortic Valve
A series of different tests help physicians identify a bicuspid aortic valve, including:
- CT scans
- Magnetic resonance imaging (MRI)
Once the defect is detected, treatment options will follow, depending on how serious the issue is.
Bicuspid Aortic Valve Treatment Options
Treatment options will depend on the severity of the birth defect. For instance, if the bicuspid aortic valve is detected at birth, the Cleveland Clinic states that surgical treatment must be started immediately. For less severe cases, some people may never need treatment. However, around 80% with a bicuspid aortic valve will require treatment.
The surgical procedure generally consists of inserting a catheter (tube) into the narrowed aortic valve. A balloon attached at the end of the catheter will expand once in place, and help open the aortic valve.
Medications are also a treatment option and are used to help lessen symptoms and prevent additional complications. Common medications prescribed for a bicuspid aortic valve include:
- Inotropic agents to help the heart pump faster
- Medications to help slow down the ACE enzyme
- Angiotensin receptor blockers
Risk Factors and Complications of Bicuspid Aortic Valve
Possible complications involved with infants having a bicuspid aortic valve include:
- Blood leakage into the back of the heart
- Heart Failure
The National Institutes of Health (NIH) suggests that you should call your physician immediately if your baby or child:
- Turns bluish or pale
- Loss of appetite
- Extreme fatigue
Causes of Bicuspid Aortic Valve
In some instances, a bicuspid aortic valve tends to run in families and in other situations there may not need be a way to tell what caused it. Medications have also been associated with the birth defect, especially if taken during the first trimester when the infant’s heart is still developing.
Zofran, also known as ondansetron or Zuplenz, as mentioned earlier, has been linked to heart malformations if pregnant take the medication during pregnancy. GlaxoSmithKline, the makers of Zofran, is aware of the issues, as the company is already facing numerous lawsuits after infants were born with serious birth defects. Yet, the drug manufacturer continues to market Zofran as off-label for morning sickness.
If you took Zofran while pregnant and your baby was born with heart defects or any other type of birth defect, keep in mind that you have the legal right to file a Zofran lawsuit against the responsible party. GlaxoSmithKline has become a company notorious for misrepresenting their medications, including Zofran. In 2012, GlaxoSmithKline settled a $3 billion fraud settlement after misrepresenting a number of antidepressant medications, including Avandia, Wellbutrin, and Paxil.
For additional information on Zofran lawsuits and how the process works, see our article Zofran Lawsuits.