Zofran – Prescribed Anti Nausea Drug That Is Known To Cause Serious Birth Defects

Zofran, also known as Ondansetron, is a drug developed by GlaxoSmithKline (\"GSK\") hat has been prescribed to pregnant womento assist with severe nausea (morning sickness).  However, Zofran’s main purpose is to help patients who are undergoing chemotherapy for cancer.  The FDA has never approved Zofran to be prescribed to pregnant women.  To prescribe Zofran to moms that are battling severe nausea due to pregnancy is known as “off label treatment.”  The intended consumer of the drug is not pregnant women. 

When Zofran is used by pregnant moms, the moms are unwittingly putting their baby at risk.  Zofran has been linked to serious birth defects.  Some of the side effects that are linked to Zofran are:

  • Death to the infant
  • Heart defects
  • Kidney deformity
  • Fetal growth restrictions
  • Birth Defect
  • Heart murmur
  • Atrial Septal Defect
  • Ventricular Septal Defect
  • Hole in the heart
  • Cleft lip
  • Cleft palate
  • Hydronephrosis
  • Hypospadia
  • Musculoskeletal abnormality


Three medical studies that support these findings are:

  • Pasternak, et al., Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes, New England Journal of Medicine (Feb. 28, 2013) (the “Pasternak Study”)

  • Andersen, et al., Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations— A Register Based Nationwide Control Study, presented as International Society of Pharmaco-epidemiology, Montreal, Canada (2013) (the “Andersen Study”)

  • Danielsson, et al., Ondansetron During Pregnancy and Congenital Malformations in the Infant (Oct. 31, 2014)

The above articles and many others have shown that Zofran does in fact pass to the fetus when taken. In fact, Zofran remains active within the fetus much longer than it does in the mother.

The studies also show that babies whose mothers took Zofran during pregnancy are doubled risk of heart defects and have a 30% increase in birth defect overall. The studies reflect that 4.7% of the moms who took Zofran had a baby with a birth defect versus the 3.5% of women who did not use Zofran.


In 2012, GSK (Zofran Manafacturer) was ordered to pay a THREE BILLION dollar fine for illegal marketing to promote its medicines.  This included giving kickbacks to doctors who prescribed its’ medicines.

GSK pled guilty to the charges brought against the company. These charges included fraud allegations and failure to report safety data.

This was the largest healthcare fraud settlement in the history of the United States. But it still didn\'t come close to the 8 billion dollars GSKbrought in that year from the sale of Zofran alone.


At the end of 2012, a recall was issued for 32-mg intravenous (IV) Zofran.  The FDA also issued several more warnings about the risk of severe, life threatening heart rhythm disorders that had been under investigation.  The recall was issued due to a safety study that was published in the summer of 2012 by GSK.


If you took Zofran during your pregnancy and your child was born with a birth defect, you should immediately call Jose Orihuela, Attorney at Law. Call and you will immediately speak with Jose Luis Orihuela, the attorney, and get the answers you need.

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