Zofran Birth Defect Lawsuits

by Marilyn McGoldrick, Esq.

Published on June 17, 2015

They say that those that forget the past are doomed to repeat it.  More than 50 years ago, thousands of babies born to women that were prescribed Thalidomide for morning sickness developed severe birth defects.  The severity of the babies’ injuries was so great that many did not survive to term.  But did you know that similarly prescribed drugs – prescriptions that are being written as you read this –  are still given to pregnant women today? More than 50 years after the horrors of Thalidomide doctors are still prescribing Zofran (generic name: ondansetron) even though studies have shown that Zofran use is associated with the following serious birth defects and major congenital malformations:

Serious Birth Defects

  • Heart (cardiac) defects
  • Musculoskeletal abnormalities (like club foot)
  • Mouth deformities (like cleft palate and lip)
  • Craniosynostosis (abnormal shape of skull, may not have enough space for the brain, and cause eating, vision, and mental health issues)
  • Kidney malformations
  • Fetal growth restrictions

Off-label Prescribing of Zofran

Zofran is manufactured by pharmaceutical giant GlaxoSmithKline (GSK). In 2012 the U.S. government charged GSK with illegal marketing and to paying kickbacks to doctors to prescribe Zofran and other drugs for off-label uses. Zofran is only approved to treat nausea associated with chemotherapy, radiation, or surgery. Yet doctors – with GSK’s encouragement – prescribe it to pregnant women for nausea. GSK paid a $3 billion dollar file and plead guilty to the charges it had paid doctors to promote drugs like Zofran for off-label use.

Morning Sickness Treatment

Morning sickness can be a serious illness. Up to 80% of women are thought to experience nausea and vomiting during pregnancy, and 10-15% of those women are receive drugs to prevent morning sickness. The most extreme version of morning sickness, the relentless vomiting called hyperemesis gravidarum, can put both mother and unborn child at risk from dehydration and significant weight loss.

Safer Alternatives to Zofran

The FDA has approved one drug, Diclegis, to safely treat morning sickness. A combination of the antihistamine doxylamine succinate and vitamin B6 (pyridoxine hydrochloride), it is not associated with birth defects in the first trimester. GSK has never asked the FDA to approve Zofran for pregnancy-related nausea, and has never conducted any studies of its effectiveness or risks for pregnant women and their unborn children. The FDA has never approved Zofran for this purpose.

Study Finds Zofran Doubles Cardiac Malformation Risk

The largest study to date, of 900,000 Danish women, was published in 2013. It found that taking Zofran doubled a woman’s risk of bearing a child with a cardiac malformation birth defect, leading to a 30% increased risk of major congenital malformations – serious birth defects.

Experienced Birth Defect Lawyers

Since the 1980s, Thornton Law Firm lawyers have represented families of children injured by birth defects caused by pharmaceutical drugs such as Paxil, Prozac and other SSRIs, as well as birth defects caused by exposure to toxic substances including semiconductor chemicals, glycol ethers, pesticides, and solvents that are hazardous to reproduction.

Have You Taken Zofran?

One million pregnant women take Zofran for morning sickness each year. Most morning sickness occurs in the first trimester of pregnancy, when the fetus is the most vulnerable to developing birth defects. If you took Zofran and your child was born with a birth defect you may have the right to bring a lawsuit for damages. Call the experienced birth defect team at Thornton Law Firm at 888-341-1405 or tell us your story here to receive a free, confidential evaluation of your legal rights.  Like all legal claims, birth defect claims are subject to strictly enforced legal time limits. Do not delay seeking legal advice.

Anti-Nausea Drug Zofran May Increase Risk Of Severe Birth Defects








By Marilyn T. McGoldrick, Esq.

Published on March 16, 2015

The anti-nausea medication Zofran, marketed off-label to pregnant women to prevent morning sickness, has been found in recent studies to be associated with an increased risk of birth defects. A study by Dr. Gideon Koren of the The Motherisk Program of Toronto, Canada found that women prescribed ondansetron (the generic name for Zofran) suffered a two-fold increased risk of cardiac malformations, leading to a 30% increased risk of major cardiac (heart) defects. The study, published in the December 2014 issue of American Journal of Obstetrics and Gynecology, was a retrospective analysis of 900,000 Danish women. Thornton Law Firm, a leader in birth litigation for three decades, is pursuing claims on behalf of families whose children were born with severe cardiac birth defects.

Zofran is approved for the treatment of nausea and vomiting in patients undergoing chemotherapy and radiation, and to alleviate nausea in patients following surgery. It is not approved to treat nausea and vomiting in pregnant women. In fact, Zofran’s manufacturer, GlaxoSmithKline (GSK), paid a $3 billion dollar fine in 2012 to settle charges by the U.S. Justice Department that it had illegally promoted Zofran to prevent nausea in pregnant women. Since 1991 GSK has paid $7.56 billion in civil and criminal penalties involving illegal marketing, fraud, failure to report safety data, and other illegal practices, according to the watchdog group Public Citizen.

Two lawsuits have recently been filed on behalf of children born with serious cardiac birth defects after their mothers took Zofran to treat morning sickness. The lawsuits allege that “GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses.” They further allege that GSK has received more than 200 reports of birth defects associated with Zofran, yet never disclosed those reports to pregnant women or to their physicians.

If you took Zofran while pregnant and your child was born with a birth defect, you may have a legal claim against GlaxoSmithKline. Thornton Law Firm’s birth defect lawyers specialize in helping families whose children have suffered birth defects recover the compensation they deserve. If you believe your ingestion of Zofran while pregnant caused your child’s birth defect, please call our Zofran birth defect attorneys at 888-341-1405 or tell us your story via our website here. All consultations are free and completely confidential.

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