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Zofran Birth Defects

Zofran Birth Defects

There may be a link between pregnant women using Zofran and serious birth defects.

What is Zofran?

Zofran is a drug manufactured by GlaxoSmithKline that was approved by the U.S. Food and Drug Administration to treat nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Its active ingredients are ondansetron or ondansetron hydrochloride. Zofran is available as 4 mg and 8 mg tablets, 4 mg and 8 mg orally disintegrating tablets, and oral solution (4 mg/5 mL). It is also available as an injection for intravenous use (2 mg/mL).

Off-Label Use & Consequences

Recently, the off-label use of Zofran to treat nausea and vomiting in pregnant women is believed to have caused birth defects in the first trimester of pregnancy in some cases.

The controversial use of Zofran by pregnant women has been the subject of several studies in the last decade. While initial studies indicated Zofran did not harm fetuses, later studies showed a significant risk increase for birth defects. One study detected a twofold increase in congenital heart defects associated with ondansetron during the first trimester of pregnancy.  Yet another study noted, “ a 2-fold increased risk for cleft palate associated with ondansetron [Zofran] taken…in the first trimester of pregnancy.”

According to the FDA, taking Zofran while pregnant can potentially lead to serious birth defects, yet many doctors still frequently prescribe it. Even worse, since morning sickness is most often associated with the first trimester of pregnancy, women prescribed Zofran are taking it during an infant’s most crucial development period. The most common types of birth defects that can potentially come from Zofran include:

  • Musculoskeletal anomalies
  • Mouth deformities such as cleft palate
  • Heart defects
  • Fetal death

In July 2012, GlaxoSmithKline resolved a series of civil and criminal complaints brought against it by the federal government. As stated in the Department of Justice’s press release: “As part of a global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting drugs Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off label, non-covered uses and paying kickbacks to physicians to prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex.” To read the complete DOJ press release, click here.

Protect Your Rights

Ashcraft & Gerel, LLP is investigating the safety of Zofran and possible lawsuits against the manufacturers of Zofran. If you feel that you or someone you know should be compensated for harm caused by use of Zofran, please contact us online or call us at 800-829-7037 to speak with an attorney today. All consultations are free and completely confidential.