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Zofran Pregnancy Risks

Zofran, a potent anti-nausea medication that is often prescribed off-label for women during pregnancy, has been linked to an increased risk of causing birth defects.

Women who are pregnant and suffer from morning sickness should be aware of new research that links an increased risk of birth defects to Zofran.

If you, or someone you love, took Zofran, while pregnant and your baby was born with birth defects, you may have legal rights. The pharmaceutical attorneys at Simmons Hanly Conroy are investigating the rights of women who took Zofran during pregnancy and whose children were born with birth injuries like cleft palate, cleft lip, heart murmur, and other pregnancy complications.

If you believe Zofran may have caused your child’s birth defects or pregnancy complications, we may be able to help. Call the Zofran attorneys at Simmons Hanly Conroy to learn more: 1-877-318-0580.

What is Zofran?

Zofran is a prescription drug used to prevent nausea and vomiting in cancer and post-surgery patients. The drug was developed by the international pharmaceutical company GlaxoSmithKline in the mid-1980s. The U.S. Food & Drug Administration approved it for use in 1991, but limited that approval to treating nausea and vomiting after surgery and nausea and vomiting related to chemotherapy or radiation treatments.

Zofran became a top selling drug in the United States, securing $1.3 billion in sales in the first nine months of 2006. Later that year, the drug’s patent protection expired and the FDA granted approval for a generic version.

Zofran Marketed for Unapproved Use

With a generic version now available to cancer patients, GlaxoSmithKline began exploring alternate markets for Zofran. From 1983 to 2013, morning sickness did not have an approved FDA treatment. The company began marketing its drug to women suffering from morning sickness and the more severe version of morning sickness called hyperemesis gravidarum.

In 2012, GlaxoSmithKline paid a $3 billion settlement to the U.S. Department of Justice to resolve civil allegations that it promoted several drugs for off-label uses, including Zofran for the treatment of morning sickness in pregnant women. The settlement also included resolving claims that the pharmaceutical company paid kickbacks to health care professionals to induce them to promote and prescribe Zofran.

Zofran Birth Injury Risks

While Zofran has been prescribed for the off-label use to treat morning sickness, the drug’s label does not list the increased risk of causing birth defects. This has led to Zofran lawsuits alleging that the drug manufacturer illegally marketed Zofran and negligently failed to warn consumers and health professionals about the actual risks of taking Zofran during pregnancy.

Recent studies have found an increased risk of the following birth injuries when mothers took Zofran while pregnant:

  • Cleft lip
  • Cleft palate
  • Heart defects, including:
    • Atrial septal defect (hole in the heart)
    • Ventricular septal defects (VSD)
    • Tetrology of fallot (TOF)
    • Hypoplastic heart syndrome
  • Renal agenesis (born with one kidney)
  • Miscarriage

Zofran Medical Studies

Zofran has never been approved to treat morning sickness in pregnant women. In addition, very little is known about the safety of Zofran’s use during pregnancy. What studies have been done suggest that taking Zofran, especially during the first trimester, increases the risk of birth effects. Unfortunately, morning sickness is often worse during the first trimester, and women are more likely to be prescribed the drug during this critique time of development.

A 2013 Danish study reviewed a national registry of 900,000 birth records from 1997 to 2010 and found a 30 percent increased risk of birth defects and a twofold increase in risk of heart defects attributed to the mother taking Zofran.

Other research includes:

  • In 2012, the Center for National Birth Defects Research and Prevention found a 2.4-fold increased risk for cleft palate and cleft lip when Zofran was taken during pregnancy.
  • In 2012, the FDA issued a safety warning that patients taking Zofran have an increased risk of suffering a potentially fatal arrhythmia Torsade de points. The warning recommended that patients with certain electrolyte abnormalities, caused by severe nausea and vomiting, undergo ECG monitoring while taking Zofran.
  • In 2014, the Toronto Star, a Canadian newspaper, conducted a Zofran investigation and reviewed 2012 records from the FDA’s public side-effect report database. Reporters discovered that at least 20 Canadian women treated with Zofran during pregnancy reported newborns with serious birth injuries including heart defects and kidney malformations. Two infant deaths were also reported.

Dr. Gideon Koren, M.D., a professor of pediatrics, pharmacology, pharmacy, medicine and medical genetics at the University of Toronto, wrote the following about Zofran in the Oct. 25, 2013, edition of Pediatrics News:

“Based on the available data, one therefore needs to be cautious with (Zofran), considering the potential risk of cardiac malformations and oral clefts with first-trimester exposure, which needs to be studied further.”

Zofran Birth Injury Lawsuit

If you or someone you loved took Zofran while pregnant and had a baby with a birth defect such as a cleft lip, cleft palate or other congenital birth defects, you may have a legal claim.

The Zofran lawyers at Simmons Hanly Conroy are currently investigating the legal rights of parents whose children were harmed by Zofran. Contact us today for a free and confidential consultation regarding your rights. We may be able to help you secure justice for your child.


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