More than 30 lawsuits have been filed by parents alleging that taking anti-nausea prescription Zofran for morning sickness during pregnancy caused birth defects in their children including congenital heart defects, cleft lip and cleft palate.
The suits target GlaxoSmithKline LLC’s alleged “off-label” marketing of Zofran, which the U.S. Food and Drug Administration approved in 1991 for the treatment of nausea and vomiting related to chemotherapy and surgery. The cases, citing various clinical studies mostly on animals, allege that GSK failed to warn doctors of the side effects of the drug when used in women to treat morning sickness in the first trimester of pregnancy.
