New information has been released regarding GlaxoSmithKline’s anti-nausea drug Zofran. According to the report, by a combination of Plaintiff’s attorneys, recent studies have begunto establish a connection between Ondansetron, Zofran’s active ingredient, and severe birth defects. These defects include cleft lip, cleft palate, and congenital heart defects. Additionally, recently filed lawsuits claim that GlaxoSmithKline (GSK) was aware of the risks Zofran posed to fetuses, yet continued marketing the drug to obstetricians and gynecologists as a safe treatment for morning sickness.
The lawsuits allege that GSK has been aware of Zofran’s dangers since at least the late 1980s. Furthermore, the complaints allege Zofran was unlawfully marketed as a treatment for morning sickness, despite knowledge of its harmful effects on fetal development. The complaints provide an overview of tests conducted by GSK to determine Zofran’s effects in pregnant rabbits and rodents. These tests showed evidence of Zofran’s toxicity, including fetal deformities and intrauterine deaths. Subsequently, the complaints accuse GSK of knowing Zofran readily crosses human placental barriers during pregnancy, while continuing to market the drug as safe.
GlaxoSmithKline has never performed clinical trials studying Zofran’s effect on pregnant women or fetal development. GSK has also never initiated the process required for FDA approval for treatment of morning sickness with Zofran.
In 1991, the US Food & Drug Administration (FDA) approved Zofran for chemotherapy-induced nausea and vomiting, in addition to nausea and vomiting associated with radiation therapy, anesthesia and surgery. Soon thereafter Zofran prescriptions were written for pregnant woman. Before long, GSK received notification of two children born with birth defects after their mothers had taken Zofran during the first trimester. By 2000, GSK received over 30 similar reports. As of 2015, there are over 200 reports associating Zofran with birth defects. During this time, GSK and has never modified Zofran’s label to include warnings of child birth defects.
If you or someone you know thinks they have been injured by Zofran contact us today for a free consultation. Our senior partner, Paul Rheingold, is available to discuss your case: (212) 684-1880