Zofran (ondansentron) is a drug manufactured by Glaxo Smith Kline as an anti-nausea medication. It was originally marketed for patients undergoing chemotherapy and other surgeries that produce severe nausea and vomiting. However, its effectiveness at treating nausea made it appealing to pregnant women who were suffering from morning sickness.
Although the Federal Drug Administration (FDA) considers prescribing Zofran for morning sickness to be an “off label” use of the drug, thousands of doctors wrote prescriptions for pregnant women. The lack of FDA approval means that no conclusive clinical studies were conducted to determine possible negative effects on mother or baby. “Off label” use does not mean “not allowed.” In fact, as a for-profit corporation, Glaxo Smith Kline went to great lengths to push the drug for off label use.
Recent research has linked Zofran to several serious birth defects, including heart defects and cleft palates. As a result, Glaxo Smith Kline was ordered by the U.S. Justice Department to pay $3 billion in fines for illegally marketing Zofran and several other drugs for off label use. In fact, GSK was found to have paid kickbacks to doctors for prescribing the various medications for off label use.
In the 1980s, GSK conducted several animal studies indicating that Zofran did cross the placenta from mother to child. Additional studies confirmed that the drug passes through the placenta in “significant amounts,” and remains active in the fetus longer than in the mother.
Common Defects Associated with Zofran
- Atrial Septal Defect (hole in the heart)
- Ventricular Septal Defect (hole between two ventricles)
- Heart murmur
- Cleft palate and cleft lip
- Malformation of the kidney
- Deformity of the mouth
- Fetal Growth Restriction
- Fetal death
In 2013, researchers concluded that Zofran doubled the risks of heart defects in babies. In fact, one out of every 20 newborns exposed to the drug was born with some form of birth defect (compared to one out of every 28 without exposure). This study looked at 900,000 pregnancies where 1250 of the expecting mothers took Zofran during the first trimester of their pregnancy.
Hancock Injury Attorneys – Birth Injury Law Firm
Mike Hancock has been practicing law for over 25 years, and he has represented many families in birth injury cases. He knows how difficult these cases can be for parents and children alike. Mr. Hancock’s main focus in all birth injury cases is to help the families get the compensation they need to get their lives back on track. If you or a loved one has a baby born with a birth defect after being exposed to Zofran, you should consider filing a lawsuit. If you were never informed of the potential risks of taking the medication while pregnant, your doctor may have been negligent in the prenatal care of you and your child. In addition to warning other pregnant women about the risks, you may be able to obtain compensation for your medical bills, pain and suffering, lost wages, and other associated costs. Contact us today for a free consultation.