Anti-Nausea Drug Zofran Has Serious Side Effects on Mom and Baby

May 6, 2015 | Crandall & Pera Law
Anti-Nausea Drug Zofran Has Serious Side Effects on Mom and Baby

The U.S. Food and Drug Administration has warned that taking Zofran or its generic equivalent, ondansetron, while pregnant can cause serious birth defects. The product is still available because it has other uses, but pregnant women and doctors should be aware of the potential dangers of the drug.

What is Zofran?

The drug blocks natural chemicals that are responsible for nausea and vomiting. Zofran can be taken orally or intravenously. Zofran was originally intended to treat cancer victims suffering nausea as a result of surgery, radiation or chemotherapy. Because the drug is so effective, doctors are turning to the anti-nausea treatment for pregnant patients experiencing morning sickness.

According to the National Institute of Health, morning sickness usually occurs for the first three or four months of pregnancy, and eventually tapers off. While uncomfortable and frustrating, morning sickness poses very little health risks unless it is so severe that the pregnant mother loses a lot of weight because of “severe vomiting.”

Complications with morning sickness

If the nausea is severe and accompanied by vomiting, doctors can prescribe an anti-nausea drug. Unfortunately, drugs like Zofran are more likely to be prescribed during the first trimester, when the developing fetus is most vulnerable. The studies surrounding the drug are controversial, but four main potential birth defects have been identified:

  • Musculoskeletal anomalies, such as club feet

  • Mouth deformities, like cleft palate

  • Jaundice

  • Heart defects

If you are experiencing morning sickness and your doctor decides to prescribe medication, it is important that you discuss any potential side effects. While the studies regarding the effect of Zofran on pregnant women may not all agree, the Department of Justice filed a lawsuit against the drug’s maker, GlaxoSmithKline, in 2012 for promoting off-label use of Zofran and other drugs. The lawsuit resulted in a $3 billion settlement.

GlaxoSmithKline readily admitted that the drug had not been tested on pregnant women; some patients taking the drug have reported rashes, shortness of breath, constipation, irregular heartbeat, dizziness, fainting, and difficulty breathing and swallowing.

If you were prescribed Zofran or its generic equivalent during your pregnancy, please contact Crandall & Pera Law for more information. As a premier medical malpractice and liability law firm serving Ohio and Kentucky, we can help you understand your rights as a victim, and counsel you as to your next steps if you wish to pursue compensation.