Zofran Birth Defects
Unapproved Use Leads to Zofran Birth Defects
The U.S. Food and Drug Administration (FDA) originally approved Zofran, more than 20 years ago, to be used for cancer patients suffering from nausea or who became ill after taking medication to help them with pain after surgery.
GlaxoSmithKline, manufacturer of Zofran, later decided to market the drug to pregnant women suffering from morning sickness. The FDA however never approved Zofran to be used by pregnant women, meaning it was being prescribed off-label.
There is no law or regulation stopping doctors from prescribing drugs off-label.
The problem is however that the use of Zofran during pregnancy has been tied to a 2-fold increased risk of cardiac malformations and an overall increased risk of major malformations of 30 percent.
Potential Zofran Birth Defects Include:
- Congenital heart defects
- Cleft palate
- Kidney malformation
- Skeletal defects
- Fetal growth restriction
- Spontaneous abortion
Heart Defects Linked to Zofran:
- Atrial Septal Defect (ASD): This “hole in the heart” defect in the wall that separated the two top chambers of the heart allows oxygen-rich blood to leak in to the oxygen-poor blood and blood flow through the lungs which may lead to lung and heart failure later in life.
- Ventricular Septal Defect (VSD): Similar to ASD, this defect occurs in the lower champers of the heart. Sometimes the two defects occur in the same baby.
GlaxoSmithKline is facing legal action due to the Zofran birth defects.
Lawsuits Against the Makers of Zofran
In 2012, GlaxoSmithKline plead guilty to federal charges of fraud and illegal promotion of several drugs. They paid $3 billion as part of the legal settlement for the Department of Justice allegations against the company that had promoted Zofran.
Now, GlaxoSmithKline is going back to court to defend more specific allegations about Zofran.
Zofran’s off-label use for morning sickness in pregnancy has been linked to hundreds of reports of birth defects. Studies have also found a 30 percent increased risk of birth defects, a doubled risk of certain heart defects, and even higher rates of cleft palate.
Filing a Zofran Birth Defect Lawsuit
If you took Zofran during pregnancy and your baby was born with serious health problems, don’t stay silent, and call-1-800-THE-LAW2 now! You could have the right to the payment of your medical expenses and a strong monetary compensation.
Manufactures of Zofran put profits before the health and safety of your baby and you have the right to take action.
While nothing can replace having a healthy child, a lawyer can help bring some comfort to you and your family.
How Can a Lawsuit Help?
You could be compensated for:
- Past and future medical bills
- Household accommodations
- Pain and suffering
How Much Does a Lawyer Cost?
Our attorneys will only collect a fee if they win your case. With 1-800-THE-LAW2 the call and consultation are free and either you get paid, or you don’t pay at all!
1-800-THE-LAW2 has been helping people in need of legal representation since 1985. Our lawyers have years of experience and success handling birth defect cases including SSRI Birth Defects and Pesticide Birth Defects. Call us to be connected with a lawyer who can help you get justice for your pain and suffering: 1-800-THE-LAW2.