Using Zofran Off-Label Can Lead to Birth Defects

Experienced medical product liability lawyers helping families in Memphis, Jackson and throughout West Tennessee

Zofran is a prescription drug that was formulated to relieve the nausea symptoms of cancer patients after chemotherapy treatments. The generic name of the drug is ondansetron. It is made by GlaxoSmithKline, and it was approved by the FDA in 1991. It was not approved for use by pregnant women to cure morning sickness, but that did not stop doctors in Tennessee from prescribing it. The tragic results is that many children, here and throughout the country, were born with permanent and debilitating birth defects.

When your child is born with significant defects because you or your partner was incorrectly prescribed a medication that could harm the baby, it is easy to become outraged and overwhelmed. At the law firm of Bailey & Greer, PLLC, we want to ease some of that burden. We offer aggressive and tireless representation to clients in and around Memphis, Jackson and West Tennessee whose children were born with birth defects caused by Zofran. You are not in this alone.

What GlaxoSmithKline did wrong

Ondansetron works well for its intended purpose, and it is listed on the World Health Organization’s Model Lists of Essential Medicines. The problem is that GlaxoSmithKline began marketing Zofran and doctors began prescribing it for off-label uses to populations on which it had not been tested or approved by the FDA. While it is legal for doctors to prescribe medications off-label, it is illegal for drug manufacturers to market a drug for off-label use unless it receives FDA approval for that application.

The link between Zofran and birth defects

There are several common, off-label uses for Zofran, but the most common and, unfortunately the most harmful off-label use of Zofran is for pregnant women with severe morning sickness in the first trimester of pregnancy.

Danish researchers proved the link between Zofran use in the first trimester of pregnancy and a twofold increase in congenital heart malformations and 30% increase in birth defects in newborns. This study tracked almost 900,000 women over a period between 1997 and 2010. In addition to the Danish study there have been several other studies that have shown the dangers of ondansetron for pregnant women and their children.

Common birth defects linked to Zofran use in pregnant women include:

  • Heart murmur
  • Neural tube defects
  • Cleft palate
  • Cleft lip
  • Skull malformations
  • Fetal growth restriction
  • Fetal death

Zofran birth defects Lawsuits

The U.S. government ordered GlaxoSmithKline to pay a $3 billion settlement for marketing Zofran for unapproved uses. Individuals have been filing negligence claims against the pharmaceutical giant for failing to warn their customers about the danger of taking ondansetron during pregnancy.

Women who gave birth to children with birth defects after having been prescribed Zofran during pregnancy may be entitled to file a lawsuit against GlaxoSmithKline for their negligence. There are statutory time limits that restrict when you can file a claim, so talk to a trusted West Tennessee products liability attorney right away.

Offering hope to families devastated by Zofran-related birth injuries

Helping your child with a birth defect live his or her best possible life may seem difficult, but we are here to help. At Bailey & Greer, PLLC, our experienced products liability attorneys stop at nothing to help you and your family recover. To learn more about how we have helped families in Memphis, Jackson and West Tennessee obtain the compensation they deserve, please call 901-680-9777 or fill out our contact form.