Eight years ago, Julie Hunter gave birth to a baby boy with a myriad of birth defects. Julie, who was prescribed Zofran (ondansetron) to treat morning sickness during her first trimester of pregnancy, has now filed a lawsuit in the U.S. District Court for the Northern District of Alabama against the drug’s manufacturer GlaxoSmithKline (GSK) for allegedly causing her son Talon’s chromosomal defects. He is nonverbal, and also suffers from a high narrow pallet, extra digits, seizures, glaucoma, and other life-long health problems.
Zofran (ondansetron) was first approved by the FDA as an anti-nausea medication to treat cancer patients, but has never been given the green-light as a safe and effective treatment for pregnant women suffering similar symptoms. Julie’s case joins a number of others, alleging that GSK may have illegally marketed Zofran (ondansetron) for off-label uses, leading to an increased chance of birth defects in affected children, including heart defects and cleft palates.