Zofran (ondansetron) is a prescription medication used to treat nausea and vomiting. It is an antiemetic that blocks serotonin, a neurotransmitter in the brain, from triggering the nerves that cause nausea and vomiting.
Zofran was approved for use in helping cancer patients dealing with the after-effects of radiation and chemotherapy treatments in 1991. This was the first drug designed specifically for this use, and it quickly became a popular option for helping to treat the debilitating and potentially dangerous side effects of cancer treatments.
While Zofran is approved for use in cancer patients and after surgical procedures, the manufacturer of the drug determined there was another use – alleviating nausea and vomiting in pregnant women. Approximately 80 percent of all pregnant women suffer from vomiting or nausea at some point during pregnancy, with a majority of cases occurring within the first trimester. Referred to as morning sickness, this condition can become dangerous for both the mother and baby if it is severe enough to result in dehydration and malnutrition.
The problem with Zofran use during pregnancy is that the FDA never approved the medication for this. However, GlaxoSmithKline marketed the drug for pregnant women, which led to millions of women receiving a prescription for the medication. This marketing ploy, however, failed to mention that the drug was never tested for safety when used during pregnancy.
Due to Glaxo’s marketing of Zofran and other drugs for off-label or nonFDA-approved uses, the drug manufacturer faced federal charges in 2012. Ultimately, the company agreed to pay $3 billion to settle the illegal promotion and fraud charges associated with Zofran and other medications. The reason for both the charges and subsequent settlement was due in part to the fact that the drug maker chose to market the medication for use by pregnant women, even though evidence was available starting in 1992 that showed the drug not only passed through the placenta but also presented a severe risk of causing harm to unborn babies when used within the first trimester.
The lawsuits brought against GlaxoSmithKline cited several claims, including:
- Failing to determine risks associated with the medication and ensuring its safety prior to selling it
- Failing to provide warning about potentially dangerous side effects
- Advertising the drug for uses not FDA-approved
- Misrepresentation of animal study information that showed toxicity and abnormal growth of bone
- Failing to provide proper evaluation of all safety information and available data
- Making fraudulent and false claims concerning the safety of Zofran use during pregnancy
Zofran and Pregnancy
Studies indicate there are some birth defects associated with using Zofran during the first trimester of gestation, including:
- Hearing loss
- Visual problems
- Webbed toes
- Blood pressure abnormalities
- Mental problems
- Cleft Palate/Lip – Improper formation of the upper lip or roof of the mouth
- Jaundice – Yellowing of the eyes and/or skin
- Musculoskeletal deformities
- Heart Murmurs – Irregular or abnormal heartbeats
- Atrial Septal Defect – A defect affecting the upper heart chambers
- Ventricular Septal Defect – A defect affecting the lower heart chambers
While research is ongoing in determining whether these conditions are a direct result of Zofran use, evidence has already provided significant links, with some showing a 30 percent increase in major malformations and twice the risk of malformations occurring in the heart.
The drug maker’s settlement in 2012 has led to some additional lawsuits from mothers with babies born with birth defects after taking Zofran for nausea and vomiting. If your child was born with a defect after taking this drug while pregnant, you should contact an attorney to determine your rights and potential compensation for your case.