An Illinois couple has filed a Zofran lawsuit claiming GlaxoSmithKline’s anti-nausea drug caused their son to be born with a congenital heart defect.
Zofran is an antiemetic approved for treatment of nausea and vomiting in patients who have undergone chemotherapy, radiation therapy, or surgery. Though not approved by the U.S. Food and Drug Administration (FDA) to do so, Zofran is often prescribed off-label to help with morning sickness in pregnant mothers. The drug is classified under pregnancy category B in the United States, meaning the FDA has not found adequate evidence that Zofran poses a risk to human fetuses at any stage of pregnancy. However, this classification is at odds with several studies that have linked Zofran use during pregnancy to increased risk of birth defects. These include a 2012 study by the Center for Birth Defects Research that found pregnant women who used Zofran during their first trimester to be twice as likely to give birth to a child with birth defects; and a 2014 study that associated Zofran with a more than doubled risk of giving birth to a child with a cleft palate or other congenital defect.
The Illinois Zofran lawsuit alleges that the mother took Zofran during the first trimester of her pregnancy to help with morning sickness. When her child was born, he was found to have tetralogy of Fallot, a congenital heart defect consisting of four different anatomical abnormalities. The couple says their son has already required one open-heart surgery, and they expect the need for more operations in the future.
The Zofran lawsuit alleges GlaxoSmithKline unlawfully promoted the off-label use of Zofran for morning sickness, citing material from as early as 1998. The plaintiffs further allege that GlaxoSmithKline failed to update the pregnancy warning on its drug’s label, despite mounting evidence that Zofran may increase the risk of birth defects when used by pregnant women.
If you or a loved one gave birth to a child with a congenital defect after using Zofran during pregnancy, contact Lopez McHugh today to schedule a free consultation with a Zofran lawyer. Your child may qualify for legal compensation through a Zofran lawsuit.