After the filing of multiple lawsuits as a result of birth defects in children of mothers who were prescribed Zofran (generically known as Ondanestron) to treat nausea and vomiting during pregnancy, a federal judicial panel created a consolidated docket for all Zofran cases in Massachusetts. The October 13, 2015 order from the Judicial Panel of Multidistrict Litigation will transfer 12 cases and all future Zofran cases to the Massachusetts Federal District Court to be heard by Judge Dennis Saylor. (For more information on Multi-District Litigation, see our earlier blog post.)
Zofran, manufactured by GlaxoSmithKline, LLC, is an anti-nausea drug that was approved by the Food and Drug Administration (FDA) in the early 90s to treat nausea and vomiting symptoms in patients undergoing chemotherapy or surgery. More recently, the drug has been extensively prescribed off label to treat nausea and vomiting during pregnancy, allegedly causing birth defects, such as cleft lip, cleft palate, club foot, and heart defects, resulting in the numerous product liability lawsuits.
Nausea and vomiting in pregnancy is the most common symptom associated with pregnant patients, with more than 80% of pregnant women experiencing these symptoms at some point during their pregnancy. According to a recent article published by the American Journal of Obstetrics and Gynecology (AJOG), 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the FDA.
Nearly 1 in 4 pregnant women are exposed to Zofran/Ondanestron in America
In recent years, the use of Zofran for the treatment of nausea and vomiting in pregnancy has steadily increased, and today approximately 1 in 4 pregnant American women are exposed to Ondanestron.
There are unresolved issues surrounding the fetal and maternal safety of the use of Ondanestron, including recent warnings by the FDA on its potential to cause abnormal heart conditions. A 2013 study indicated a 30% increased risk of major congenital malformations with Ondansetron use by mothers during pregnancy.
Because of the risks associated with Ondansetron use and the availability of safer, effective alternatives, the study published by AJOG, concluded that there is "no reason for women to be exposed to a drug of unproven maternal and fetal safety, which has not been labeled for nausea and vomiting in pregnancy."
SUGARMAN is investigating claims of birth defects resulting from the use of Zofran in pregnant women. Please continue to monitor our blog and our website for more information as developments arise. Please fill out a Contact Form, call us at 617-542-1000 or e-mail firstname.lastname@example.org for more information.