Zofran and Birth Defects
Product liability lawsuits have recently been filed against the maker of Zofran, GlaxoSmithKline, alleging that the drug has caused severe birth defects. As of 2013, the FDA issued a warning that women should not use Zofran during pregnancy after studies emerged indicating that pregnant women who have taken the anti-nausea drug Zofran during their first trimester have an increased chance of giving birth to a child with birth defects. Clinical research data has documented that the risks of birth defects, especially heart defects, were approximately 30 percent more likely in pregnant mothers who used Zofran during their pregnancy.
What is Zofran?
Zofran is manufactured and marketed as a treatment for cancer chemotherapy and radiotherapy patients and patients who are undergoing surgical anesthesia. Zofran lowers serotonin levels in the neurotransmitters of the brain to reduce nausea and vomiting. Because Zofran successfully lessens severe nausea, it has also come to be a common treatment for morning sickness. Zofran is not approved by the FDA for treating morning sickness, therefore Zofran is being prescribed off-label.
Doxylamine succinate and pyridoxine hydrochloride known as Diclegis is the only current Pregnancy Category A, FDA-approved prescription for morning sickness. Prescribing “off-label” means that a drug is being used in a different way than is approved by the FDA. Off-label prescriptions by doctors are legal. However, pharmaceutical companies cannot legally market a drug to a doctor or a consumer for off-label purposes.
Lawsuits are alleging that GlaxoSmithKline (GSK) marketed Zofran to doctors as a safe treatment for morning sickness even though GSK had no proven clinical studies showing that Zofran was safe for pregnant women. Zofran was widely prescribed by doctors to their patients who experience severe vomiting and nausea during pregnancy until November of 2013. At that time the FDA required that GSK put a warning on the label of Zofran prescriptions reflecting the potential risk of congenital cardiac malformations and oral clefts when used by pregnant women.
Because Glaxo failed to warn users of Zofran and doctors who prescribed Zofran of the possibilities of birth defects, some in the medical and legal experts believe that there should be accountability on the part of GSK. In fact, Kentucky and 44 other states sued GlaxoSmithKline for deceptive or false marketing on several of its prescription drugs, including Zofran. In 2010 Kentucky Attorney General Jack Conway announced that GSK paid $3.75 million dollars to resolve the lawsuit.
Zofran Birth Defects
One clinical study, published in the December 2014 American Journal of Obstetrics and Gynecology showed a 30% increased chance of cardio malformations (heart malformations) in babies who were born to mothers who took Zofran during pregnancy. Another Danish study of 1238 women who took Zofran in their first trimester documented that 58 of these women had babies born with birth defects. A study from Birth Defects Research in 2012 cited a 2.4 times increased risk of cleft palate when women used Zofran in early pregnancy.
Some of the health risks linked to exposure to Zofran in utero include:
- Atrial Septal Defect – hole in the heart
- Ventricular Septal Defect
- Heart Murmurs
- Cleft Lip
- Cleft Palate
Birth defects are the number one cause of infant death in Kentucky. Additionally, birth defects can greatly increase childhood morbidity and long-term disability. Finally, birth defects cause Kentucky families to suffer great financial burden from the costs of a life-time of medical care.
What if I think I have a Zofran Birth Defect Case in Kentucky?
Please contact Brett H. Oppenheimer, PLLC a Kentucky plaintiff attorney, who can help you to determine if you may be able to seek legal recourse and damages for the birth injuries that your child has suffered. Brett’s office is in Louisville, located just across from the Great Lawn and one block from Louisville Slugger Field.
Call Brett at (502) 242-8877 to schedule a free consultation.