Zofran, also known as Ondansetron, is an anti-emetic, a drug preventing nausea and vomiting. Its mechanism of action essentially works in the stomach by blocking the effects of chemicals, like serotonin, that stimulate nausea and vomiting. It was approved by the US Food and Drug Administration (FDA) in 1991 to prevent nausea and vomiting secondary to cancer treatments (e.g. chemotherapy or radiation therapy), anesthesia, and surgery. GlaxoSmithKline (“GSK”) is the pharmaceutical company manufacturing Zofran.
Despite its limited approval for use in cancer patients, GSK admitted to promoting the drug for “off-label” uses and recently paid a $3 billion fine to the U.S. Government. Specifically, GSK encouraged doctors to prescribe Zofran to treat morning sickness, or nausea and vomiting of pregnancy (NVP). Under U.S. law, promoting a drug for off-label uses is illegal: View Article. Zofran is still widely prescribed off-label for morning sickness without evidence establishing safety for the unborn baby. There is always a risk for the placental transfer of drugs (like Zofran) administered to the mother and reaching the fetus.
Recent studies indicate a strong link between Zofran use in the first trimester of pregnancy and an increasing risk of birth defects. These defects include:
In a 2012 study by the Slone Epidemiology Center at Boston University and the National Birth Defects Prevention Study, Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects, researchers found a 2-fold increased risk of cleft palate in infants exposed to Ondansetron (Zofran) during the first trimester.
According to the article, Is ondansetron safe for use during pregnancy?, the author, Gideon Koren MD FRCPC, states that based on available data today, “ondansetron use cannot be assumed to be safe during pregnancy”. He states the fetal safety data for ondansetron are based on fewer than 200 births as opposed to other studies involving comparable anti-emetics.
If you are taking Zofran, and you are in your first trimester of pregnancy, you should contact your doctor immediately and discuss your concerns with them about the potential link between Zofran use and birth defects. You should also take steps to ensure that your baby is developing healthily.
If you took Zofran during the first trimester of your pregnancy, and your child suffers from birth defects, you and your child are potentially entitled to compensation for damages. You should contact an attorney immediately to discuss your legal rights.
We provide free case consultations. Our attorneys have extensive experience handling cases involving dangerous drugs and defective medical devices. We will evaluate your potential case at no cost, and discuss with you all of your legal options. We focus on your case, so you can focus on yourself. Call us toll-free at 888-997-5170, or fill out our confidential online form.