Zofran Birth Defects Lawsuits

Zofran (Ondansetron) is a drug manufactured by GlaxoSmithKline, which was approved by the FDA in 1991 to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. Ondansetron is a 5-HT3 receptor antagonist, which blocks the action of serotonin in the brain which is thought to cause vomiting and nausea.

After Zofran was approved for treating nausea in patients undergoing cancer treatment, GlaxoSmithKline began marketing the drug to doctors for use in easing nausea in women suffering from severe morning sickness. However, Zofran was not approved for use in pregnant women.

Some women who had taken Ondansetron in their first trimester to treat severe nausea gave birth to infants with severe birth defects including:

  • Facial abnormalities
    • Cleft lip
    • Cleft palate
  • Skull deformities (craniosynostosis)
  • Heart defects

In July of 2012, GlaxoSmithKline (GSK) settled a massive criminal and civil claim from the U.S. Department of Justice for $3 billion in what is the largest settlement from a drug company so far in U.S. history.

zofranThe pharmaceutical giant pleaded guilty to three counts of criminal behavior for promoting the use of Ondansetron as an anti-nausea drug for pregnant women when it had not obtained FDA approval for such use. The lawsuit also accused GSK of paying kickbacks to doctors to promote and prescribe Zofran and other GSK products.

In November 2013, the FDA issued an updated warning against the off-label use of Ondansetron (Zofran) during pregnancy based on recent studies linking use of the drug and birth defects.

There have been several studies that report a possible link between Zofran and birth defects, however one of the more prominent studies that was published in the American Journal of Obstetrics & Gynecology (AJOG) in December 2014 was conducted by Duchesnay Inc., the manufacturer of Diclegis, which happens to be an FDA approved anti-nausea medication for pregnant women.

The new litigation centered on the use of Zofran in the first trimester on behalf of women whose infants have been born with significant birth defects and whether or not a link can be proven to exist between the defective drug, Zofran and the injuries to these children.

According to the AJOG, the use of Ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013. If you are pregnant and you have been taking Zofran to treat severe nausea and vomiting, or if you used Zofran during your first trimester and you have given birth to a child with birth defects, you might consider talking to a personal injury attorney who handles drug liability cases. If your child is going to require ongoing medical treatment and special care at home due to these birth defects, you might qualify to bring a lawsuit on your child’s behalf to compensate you for current and future medical costs, pain and suffering and other monetary damages.

Paulson & Nace, PLLC protects the victims of defective drugs in the Greater Washington, D.C. metro area and throughout West Virginia. If you have questions about the lawsuits against GlaxoSmithKline, or if your child was born with a birth defect after you took Zofran during pregnancy, please contact our office right away to learn more.