SOURCE: Kelley/Uustal


March 18, 2015 13:12 ET

Kelley/Uustal Law Firm: Pregnant Women Suffering NVP Beware Zofran; Anti-Nausea Drug Marketed by Drug Maker May Lead to Birth Defects

FORT LAUDERDALE, FL--(Marketwired - March 18, 2015) - With the growing number of lawsuits claiming personal injury and birth defects caused by the popular anti-nausea drug Zofran, pharmaceutical product liability law firm Kelley/Uustal has drafted background and guidance information for expectant mothers who have been prescribed the drug.

Zofran is the brand name of the anti-nausea drug ondansetron. The drug was approved by the FDA only to reduce nausea resulting from cancer treatments, including chemotherapy and radiation therapy, and to treat patients suffering from nausea associated with general anesthesia. Zofran later gained wide-spread use as an off-label treatment of nausea and vomiting in pregnancy (NVP), the clinical term for morning sickness.

The FDA as recently as late 2013 issued an updated warning concerning Zofran's use for nausea and vomiting among pregnant women. However, obstetricians continue to prescribe Zofran to their patients suffering morning sickness.

This unapproved use has led to hundreds of documented cases of serious health issues for children and their mothers. Zofran can cause congenital heart defects, kidney malformation, skull abnormalities, limb defects, cleft lip and cleft palate, miscarriage, other serious pregnancy complications, and even death.

According to the National Institutes of Health, Zofran/ondansetron "is not labeled for use in NVP in either the United States or Canada. Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy."

In one case, a Boca Raton, Florida, baby was born in 2014 with holes between the upper chambers (atrial septal defect) and lower chambers (ventricular septal defect) of his heart. He also has a heart murmur and a faulty heart valve. The mother's obstetrician prescribed Zofran for morning sickness during her first trimester.

Another South Florida Zofran user suffered pregnancy complications, including a placental bleed, after being prescribed the drug during her first trimester, a critical time when the fetus' brain, spinal cord and heart are developing rapidly.

The widespread use of Zofran for NVP largely resulted from drug maker GlaxoSmithKline's aggressive drug marketing tactics. Such schemes later were found by the U.S. Government to be illegal: GlaxoSmithKline in July 2012 pleaded guilty and paid $3 billion in penalties to resolve its criminal and civil liability for promoting certain prescription drugs, including Zofran, for unapproved uses. It was the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company, according to the US Justice Department.

If you are pregnant and are suffering from NVP, consult with your physician about those medications or over-the-counter remedies deemed safe to treat the condition. Among its recommendations, the U.S. Food and Drug Administration advises patients using Zofran/ondansetron to:

  • Discuss the drug with your physician or healthcare professional and to not stop taking the drug without first discussing it with your doctor or healthcare professional.
  • Be aware that physicians might order an electrocardiogram (ECG, EKG) to monitor heart rate and rhythm. Moreover, physicians might order such tests for patients with electrolyte abnormalities, congestive heart failure, or bradyarrhythmias.
  • Immediately contact your healthcare professional or seek emergency care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Zofran / Ondansetron.

About Kelley/Uustal

With law offices in Fort Lauderdale, West Palm Beach and the Florida Keys, the law firm of Kelley/Uustal is a leading personal injury practice and trial law practice serving clients throughout the state of Florida. The firm has earned significant jury verdicts and legal settlements in the areas of tobacco litigation, automobile accident, workplace injuries, product liability and health-related cases. For more information, visit or call 954-522-6601.

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