In 1991, the US Food & Drug Administration approved Zofran, a powerful anti-nausea drug manufactured by GlaxoSmithKline, for the treatment of severe nausea and vomiting in cancer patients. And while Zofran’s approval would eventually be extended to patients undergoing surgical anesthesia, the drug has never been approved for use during pregnancy. According to the US Department of Justice, GlaxoSmithKline wasn’t deterred by this lack of approval, and quickly began promoting the drug as an “off label” morning sickness treatment.
But now, after multiple studies have found an increased risk of cleft palate and congenital heart defects in children prenatally exposed to Zofran, families are filing Zofran birth defect lawsuits.
Banville Law is following the ongoing Zofran litigation carefully. Here you’ll find all the latest developments and breaking legal news.