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Defective Drugs

Zofran Birth Defects Lawsuit

This Alert Affects:

Mothers who were prescribed Zofran during pregnancy and gave birth to a child with a birth defect.

What Is Zofran?
Zofran (ondansetron) is a prescription drug that has been approved by the FDA to treat extreme cases of nausea and vomiting following chemotherapy or surgery.
What Types of Birth Defects Have Been Linked to Zofran?
Studies have found that taking Zofran during pregnancy increases the risk of the baby developing heart defects, mouth defects such as cleft palate or cleft lip, and musculoskeletal abnormalities.
How Could a Lawsuit Help Me?
By filing a lawsuit, you may be able to receive compensation for medical bills, pain and suffering, and other damages you and your child suffered as a result of taking Zofran.
Type of Lawsuit
Mass Tort

If you were prescribed Zofran for morning sickness and your child was born with a birth defect, you may be eligible to receive compensation through a lawsuit. Attorneys are currently investigating allegations that the drug, which was never approved for use in pregnant women, can cause cleft palate, heart problems and other birth defects in newborns. It has also been alleged that the company that makes Zofran encouraged doctors to prescribe the drug for morning sickness in violation of FDA rules and regulations and failed to warn both patients and doctors about the birth defect risk associated with its drug.

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If Zofran Was Never Approved for Use During Pregnancy, Why Did My Doctor Prescribe It to Me for Morning Sickness?

GlaxoSmithKline allegedly engaged in a marketing campaign to encourage doctors to prescribe Zofran for morning sickness, even though such a use for the drug was not approved by the FDA. This practice, known as “off-label marketing,” is illegal.

Although the FDA approved Zofran to treat severe nausea and vomiting following surgery or while undergoing chemotherapy, the FDA did not approve Zofran to treat morning sickness. As such, very little is known about the drug’s effects on children developing in the womb. In recent years, researchers have discovered that taking Zofran during pregnancy is associated with an increased risk of birth defects.

In July of 2012, GlaxoSmithKline agreed to pay fines to settle allegations claiming the company: 1) promoted Zofran and several other drugs for off-label (unapproved) uses; and 2) paid kickbacks to doctors who prescribed these medications for off-label uses, though the company denies the allegations. When GlaxoSmithKline agreed to settle the lawsuit, the Department of Justice stated that the “resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”

What Types of Birth Defects Are Associated with Zofran?

Zofran may cause the following types of birth defects:

  • Heart defects, such as atrial septal defect (ASD), ventricular septal defect (VSD) or heart murmur

  • Cleft palate or cleft lip

  • Musculoskeletal anomaly

  • Jaundice

  • Organ malformations

  • Fetal growth restriction, causing babies to be born weighing less than five pounds

An investigation by the Toronto Star found that Canadian women who took Zofran during pregnancy experienced “serious suspected side-effects.” The investigation revealed that Zofran may have caused two infant deaths, as well as multiple cases of newborns born with heart defects and kidney malformations.

In addition, Pediatric News reported that at the August 2013 meeting of the International Society of Pharmacoepidemiology researchers presented a study finding a twofold-increased risk of congenital heart defects associated with Zofran during the first trimester of pregnancy.

Furthermore, a study released in January 2012 by the Center for Birth Defects Research and Prevention found an increased risk of cleft palate for babies exposed to Zofran during the first trimester of pregnancy. 

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