Zofran anti-nausea medication linked to Birth Defects. Zofran (ondansetron) is a prescription medication manufactured by GlaxoSmithKline and FDA approved to treat nausea and vomiting in chemotherapy and surgery patients. Often prescribed "off-label" for morning sickness in pregnant women, Zofran has never been proven safe for the unborn child nor has the FDA approved it for this reason.
While doctors are not prohibited from prescribing drugs "off-label", drug manufacturers on the other hand are prohibited by federal law from promoting their products off-label. In 2012, GlaxoSmithKline entered into a $3 billion settlement with the United States Justice Department to resolve allegations of fraud and illegal promotion of sZofran anti-nausea medication linked to Birth Defects.everal prescription medications, including Zofran.
In recent years, several studies have linked the use of Zofran in the first trimester of pregnancy with a significant increase in the risk of birth defects including, but not limited to: Cleft Lip, Cleft Palate, Craniosynostosis (skull deformities), Musculoskeletal Defects, Heart Defects (Heart Murmurs, Atrial Septal Defects &Holes in the Heart), Kidney Defects (including Hydronephrosis, water inside the kidney), Fetal Growth Restriction.
The Simon Law Firm is currently investigating claims of parents who believe exposure to Zofran may have caused their child's birth defects. Visit Simon Law’s Dangerous Drugs Page