Information About the Zofran Lawsuit

Women taking Zofran to treat morning sickness did not know they were risking the wellbeing of their unborn child!

What Is Zofran?

Zofran (ondansetron) is manufactured by GlaxoSmithKline. The anti- nausea drug works by blocking the effects of serotonin, a natural substance which may cause nausea and vomiting.

While Zofran is NOT FDA-approved for use during pregnancy, it has been commonly prescribed by doctors to treat morning sickness. It has been estimated that perhaps over 1 million pregnant U.S. women were prescribed either Zofran or its generic form.

Approximately 50% of women experience will experience nausea and vomiting during their pregnancy (NVP). Some women experience NVP so severe that they will require medical intervention.

Unfortunately, there was no FDA approved drug available to treat NVP until April 2013 when after extensive clinical data the FDA approved Diclegis for use during pregnancy.

As a result, many doctors have prescribed Zofran off-label to treat their patients with NVP.

Off-label prescribing in the U.S. is legal and commonly done. It means that the drug is not being used as specified on the drug label or packaging insert. The FDA works by approving the drug but not how the drug is prescribed. Medical professionals can prescribe the drug for any medically appropriate use.

One possible reason so many doctors wrote scripts for Zofran to treat NVP may be aggressive and illegal marketing of the drug for this use by the manufacturer, GlaxoSmithKline. In 2012, they and the U.S. Department of Justice entered an agreement that during 1998 – 2004 GSK illegally promoted their anti-nausea drug for use during pregnancy as well as paying doctors to prescribe it. As part of the settlement, GSK was slapped with a $1B fine.

Zofran Birth Defects

Even while promoting the use of their drug for the off-label use of NVP, the manufacturer did not conduct clinical studies to affirm whether or not Zofran would be safe for use during pregnancy.

However, in 2006, a small study showed that Zofran could cross the placenta during the first trimester of pregnancy. This could affect the development of the fetus increasing the risk of birth defects.

Recently, the U.S. Centers of Disease Control and Prevention, along with the Sloan Epidemiology Center at Boston University reported on a study involving over 9,000 women and data from the National Births Defects Prevention Study. They concluded that the use of ondansetron during the first trimester of pregnancy doubles the risk of cleft palate.

Another study conducted in Denmark between 1997 – 2010 of 903,207 births showed 2x the risk for major congenital heart defects linked to the use of Zofran.

How To File A Zofran Birth Defect Claim

Because of the studies linking this anti-nausea drug to the risks of serious birth defects which GSK has never warned about on its labels for Zofran, lawyers are now investigating filing claims on behalf of those families whose babies were harmed.

If you took Zofran during your pregnancy and your baby was born with serious injury such as:

  • Musculoskeletal anomalies
  • Cleft Palate
  • Heart Defects

You may be eligible for financial compensation from the drug manufacturer.

There will be a time limit for file your claim so it is recommended that you contact us immediately to see if you and your baby will qualify. As most states will allow claims brought on behalf of minors, you may still have a claim as long as your child is under the age of 18.

Please call us now or fill out the form on this page to speak with a member of our legal team. You will receive a free confidential consultation and information on whether you might have case. We do not charge a fee for this service and there will be no cost unless we receive a satisfactory settlement for you and your child.