Zofran (Ondansetron) Linked to Birth Defects

What is Zofran?

Zofran, originally developed by GlaxoSmithKline and was marketed by them in 1991, was approved by the FDA to treat nausea in cancer patients undergoing chemotherapy and radiation treatment and for postoperative surgery patients.  It has become one of the most prescribed drugs for nausea in the United States.  Zofran is also known as Zuplenz.

Zofran Risk

Off-label use (prescribed for treatment of conditions which were not included in the FDA approval) have led to health concern and harm.  The most frequent off-label use of Zofran is for treatment of nausea and morning sickness in pregnant women.  GlaxoSmithKline lead unsuspecting doctors to believe that Zofran was safe for pregnant women.  GlaxoSmithKline was fined $3 Billion in 2012 by the Department of Justice for illegally promoting Zofran for nausea treatment in pregnant women.

Studies show Zofran Linked to Birth Defects

•  Danish researchers showed that Zofran taken in the first trimester of pregnancy led to a twofold increase in babies born with heart defects.  This study tracked around 900,000 pregnancies over a 13 year period.  This study also showed a 30% increase in the risk of birth defects.
• A Swedish study in 2014, found the risks for cardiovascular defect and a cardiac septum defect were increased with the use during pregnancy.
• In 2014, a Canadian group found cases in which babies, whose mothers took Zofran while pregnant, were born with heart defects such as atrial septal defect, heart murmurs, kidney problems, jaundice, musculoskeletal anomalies and low birth weight.
• Other studies have shown a twofold increase in the risk of cleft palate and the added risk of cardiac arrhythmias and serotonin syndrome.

Birth Defects caused by Zofran can include:

• Heart Defects
  • Atrial Septal Defects
  • Ventricular Septal Defects
  • Cardiac Murmurs
  • Arrhythmia
• Cleft Palate/Lip
• Kidney Defects
• Limb Defect
• Club Foot
• Gastroschisis
• Imperforated Anus
• Duodenal Atresia
• Craniosynostosis
• Terminated pregnancy due to sonogram showing heart or other malformation
• Loss of Life/Death

If you are a loved one had a baby with a birth defect after taking Zofran, please fill out the Contact section below or call us at 1-888-725-2477 for a free consultation. All inquiries including information are kept strictly confidential by our highly experienced drug injury attorneys at Pendley, Baudin & Coffin, leaders in medical litigation.