If you took Zofran while pregnant and your child was born with a cleft lip, cleft palate and/or congenital heart defect or your mother took Zofran while pregnant and you were born with one of these conditions, please contact Hadley Matarazzo at 585.325.5150 or click here to email her for a free legal consultation.
Zofran (or ondansetron) has not been approved by the FDA to treat symptoms of morning sickness. Instead, Zofran was approved to prevent nausea and vomiting in cancer patients and patients waking up from anesthesia in the hours following a surgical procedure. Each year, more than a million pregnant women are prescribed Zofran to relieve the nausea and vomiting associated with morning sickness.
In July 2012, Zofran maker, GlaxoSmith Kline (GSK) agreed to pay $2 billion to resolve a lawsuit brought by the government under the False Claims Act. The claims that were resolved included a claim that GSK promoted Zofran for off-label, non-covered uses and paid kickbacks to doctors for prescribing the drug. The off-label, non-covered use of Zofran that GSK promoted was for treatment of morning sickness in pregnant women.
In recent years, medical studies have linked Zofran use in the first trimester of pregnancy to birth defects. These birth defects include congenital heart defects, cleft palate and cleft lip.