Zofran is a prescription medication made by GlaxoSmithKline and used to treat nausea and vomiting. It is also sold under the generic names Ondansetron and Ondansetron Hydrochloride. The FDA approved Zofran to treat cancer patients who were suffering with the side effects of chemotherapy or surgery. Glaxo convinced doctors that Zofran would be an effective and safe drug to treat their pregnant patients suffering from morning sickness. The problem was that it had never been approved by the FDA for use in pregnant women and we now know that Zofran crosses the placental barrier exposing the developing baby to the drug. Making matters worse is the fact that most women experience morning sickness during their first trimester exactly when the fetus is undergoing rapid and critical development. Thousands of lawsuits have been filed alleging that the use of Zofran during pregnancy is unsafe and can result in significant birth defects to the developing baby.
What exactly are the problems caused by Zofran and who is at risk?
The highest risk group appears to be women who took Zofran during their first trimester of pregnancy and their babies. The most common types of birth defects that can potentially be caused by Zofran use include:
- Cleft Palate and Lip
- Mouth Deformities
- Heart Defects including Septal Wall Defects (hole in the heart)
- Club foot
Babies and pregnant mothers are not the only ones at risk with Zofran. There is also evidence that Zofran can cause electrical abnormalities of the heart. The risks are greater for people who suffer from underlying cardiac conditions, a condition called congenital long QT syndrome, or those with chronically low magnesium or potassium levels. There are also other medications that can affect a patient’s QT prolongation which if taken in conjunction with Zofran may increase the risk. These people could suffer potentially life threatening heart arythmias and even death.
What is the FDA doing about this?
One of the strongest criticisms levied against the makers of Zofran is that they promoted the use of their drug to doctors for an unapproved “off label” use without warning the medical community or the public about potential side effects that they should have been aware of. A doctor may prescribe a medication to a patient for a condition not yet approved by the FDA if in his independent medical judgment it is in the best interest of his patient. The problem is that Glaxo was paying doctors to be consultants and give lectures at paid conventions to other doctors about using its drugs for unapproved off label uses.
The United States Department of Justice began an investigation and in 2012 filed criminal and civil charges against GlaxoSmithKline related to how it was marketing and selling various drugs as well as paying doctors for their participation in this scheme. That same year Glaxo agreed to pay over 3 Billion dollars to the Government to settle the allegations of deceptive and fraudulent marketing practices making this the largest health care fraud case in the history of our country.
In addition to the September 15 th Safety Alert issued to medical providers the FDA has also asked the manufacturer GlaxoSmithKline to study the interaction between Zofran and prolonged QT intervals. The label on Zofran is also being changed to include stronger warnings to patients about the risk of abnormal heart rhythms associated with Zofran. The new warnings states that anyone with QT long syndrome should not use Zofran and patients with congestive heart failure, bradyarrhythmias or low magnesium and potassium levels should take it only if they undergo EKG monitoring.
What should I do?
If you know someone who took Zofran while pregnant and had a baby with a birth defect, particularly a cleft lip or palate or a heart defect, then they may be entitled to compensation. We are currently taking new cases of people who have suffered birth defects after exposure to Zofran. Call our office for a free consultation and put our legal team to work for you.