Off-Label Morning Sickness Drug, Zofran, Linked to Serious Birth Injury

Zofran, the marketed name for the generic drug Ondansetron, was originally created in 1991 to combat nausea and vomiting caused by chemotherapy treatment or the residual effects of anesthesia after surgery. Ondansetron works by blocking the effects of serotonin in the brain, which can help reduce feelings of nausea and dizziness. This drug can be taken orally or injected, depending on the dosage required by the patient.

Despite a complete lack of clinical trials, Zofran was prescribed to expectant mothers to help combat morning sickness during the first three months of pregnancy, the trimester most crucial to a baby’s development. The use of Zofran by pregnant women has now been linked to severe birth defects, including:

  • Cleft palate
  • Cleft lip
  • Congenital heart defects, including:
    • Vetricular Septal Defect (VSD)
    • Atrial Septal Defect (ASD)
    • Tetrology of Fallot (TOF)
    • Hyperplastic Left Heart Syndrome
  • Born with one kidney
  • Musculoskeletal abnormalities
    • Limb deformities including Club Foot
    • Spina Bifida

Studies have found that the use of Zofran for morning sickness, also known as Nausea and vomiting of pregnancy or NVP, resulted in a 2-fold increased risk of cleft palate. Zofran doubled the risk of cleft palates. Similar increased risks were seen in congenital heart defects.

Never Approved

Zofran was never approved by the FDA for use in pregnant women, yet this did not prevent the drug’s manufacturer, GlaxoSmithKline, from capitalizing on the lack of FDA-approved morning sickness drugs on the market, and promoting the benefits of Zofran as a morning-sickness medication.

Manufacturer GlaxoSmithKline admitted to illegally promoting off-label use of the drug to physicians for treating pregnancy-related nausea, despite a total lack of proper testing. The multinational corporation pled guilty to fraud charges related to the marketing of Zofran and other drugs in 2012, and paid a $3 billion fee to settle the case brought against them by the US Department of Justice.

This fine was sub-divided into a $1 billion criminal fine, and a $2 billion civil penalty paid to the Federal Government under the False Claims Act.

Doctors and drug manufacturers have an obligation to inform patients of all the risks associated with the medication they prescribe. By having an informed, constructive discussion with your healthcare provider, you can determine the best course of action to continue your medical treatment. However, when doctors and their patients are misled about the safety of a drug or medication, the manufacturer is responsible for any damages, injuries or hardships suffered by a patient.

Many patients who were harmed by the use of Zofran are filing birth injury lawsuits against the drug’s manufacturer.

If you took Zofran when you were pregnant and your child experienced any medical conditions at birth, you may be entitled to significant compensation.

At The Yost Legal Group, our experienced Birth Injury lawyers will work with you from the start of your case through to the finish. Our compassionate and dedicated team will help you understand the details of your case and will fight to secure the maximum compensation for your injuries.


We’ll help get you a lifetime of care for your child. If the drug manufacturer was responsible, we will fight to seek the justice you and your family deserve.

Free consultation: Call 1-800-YOST LAW or complete the contact form below to learn more about how we can help.

Call The Yost Legal Group today at 1-800-YOST-LAW (967-8529) to speak with an experienced Defective Drug and Birth Injury attorney. Our consultation is free. And there is never an attorney’s fee, unless there is a recovery.

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