The attorneys at Gallon, Takacs & Boissoneault are currently investigating potential lawsuits on behalf of pregnant women who took Zofran (ondansetron) for off-label use while pregnant to treat morning sickness and gave birth to babies with birth defects.

Did you or anyone you know take Zofran during your first trimester and the baby was born with a defect? Find out if you or your loved one can seek compensation for your injuries by completing our free case evaluation.

Because of the manufacturers’ failure to warn pregnant patients and doctors about this increased risk, women who took this medication while pregnant may be able to file a claim seeking compensation for medical bills, pain and suffering, and other damages.

Investigations have linked use of Zofran to:

1. Birth Defects
   1. Cleft Palate
   2. Cleft Lip
2. Heart Defects
   1. Atrial septal defect
   2. Ventricular septal defect
   3. Heart Murmur

All these have been linked to use primarily in the first trimester of pregnancy. 

What is Zofran?

Zofran (ondansetron) is an antagonist that primarily acts on the nervous system. It works by blocking serotonin and increases gastric emptying, which helps reduce nausea and vomiting, and is prescribed mainly for patients who are undergoing chemotherapy, but can also be used for surgery patients.

Zofran was made by GlaxoSmithKline in the middle of the 1980s and approved for use by the FDA in 1991, with additional divisional patents being granted in 1996.  FDA approved Zofran for primary use to treat and prevent chemotherapy and radiotherapy-induced nausea and vomiting. It later was found to be effective in controlling postoperative nausea and vomiting.

Although not approved by the FDA for use by pregnant women to combat nausea and morning sickness, this drug has become a widely prescribed drug to pregnant women, mainly in their first trimester, to prevent and treat morning sickness.

Former Studies on Use of Zofran during Pregnancy

In December 2013, in BioMed Research International, Australian researchers linked the use of Zofran in the first trimester with a non-significant 20% increased risk of delivering babies with major birth defects.  In addition, researchers at Harvard University and Boston University’s Slone Epidemiology Center reviewed data pertaining to 10,383 births where 15.4% of the women had been prescribed a version of Zofran or its generic equivalent. Comparing the groups, researchers found the pregnant women who had taken Zofran during the first trimester were 2.37 times more likely to deliver a baby with cleft palate.

West Australia, Montreal, and Sweden researchers reviewed birth records between 1997 and 2013.  Conclusion of each study is remarkable with:

1. West Australia concluding that women prescribed Zofran in the first trimester where 20% more likely to deliver babies with major defects with babies reporting to be 6 times more likely to have rare kidney defects;
2. In Montreal a total of 1,368 pregnant women had redeemed prescriptions of Zofran in the first trimester. While 4.7% of women who took Zofran during the first trimester delivered babies with birth defects. Montreal’s study concluded that women who are prescribed Zofran are 4.8 times more likely to give birth to a baby with atrioventricular septal defects; and
3. Swedish researchers found similar results using the birth records from 1998 to 2012. Swedish researchers found that between 1998 and 2012, 1,349 babies born to women exposed to Zofran use during pregnancy were 1.62 times more likely to deliver babies with cardiac septum defects.

In July 2014, Toronto Star investigation found similar birth defect risks when reviewing medical records for Canadian women who submitted reports to the FDA’s Adverse Events Reports Database.  In the investigation they found 20 cases of whom were treated for morning sickness and delivered babies with various birth defects, such as kidney malformation, heart defects and two (2) deaths.

Previous Lawsuit for Promoting Zofran for Off-Label Use

In July 2012, Global health care GlaxoSmithKline LLC (GSK) faced claims by the United States Justice accusing the company of promoting various medications for off-label use and agreed to plead guilty and paid $3 billion to resolve its civil liability for alleged false price reporting practices, its failure to report certain safety data and civil and criminal liability claims arising from the company’s unlawful promotion of certain prescription drugs, including Zofran.  GlaxoSmithKline has denied the Department of Justice’s claims that Zofran was unlawfully marketed to Ob/GYNs.

If you or anyone you know has been affected by the use of Zofran, you may be entitled to compensation.  The Zofran attorneys at Gallon, Takacs & Boissoneault are dedicated to ensuring pharmaceutical companies are held responsible for the dangerous side effects of their products.  Call our Zofran Attorneys at Gallon, Takacs & Boissoneault or fill out the free case evaluation. We want to help you.