The European Medicine’s Agency (EMA) released a Pharmacovigilance Risk Assessment Committee (PRAC) update to the manufacturers of ondansetron in July which makes 3 dramatic, incorrect and misleading statements:
- Ondansetron is suspected to cause orofacial malformations
- Ondansetron should not be used in the first trimester
- Women of childbearing potential who are taking ondansetron should consider using contraception