Summary Safety Review - ZOFRAN (ondansetron) - Assessing the Potential Harm to the Fetus

Summary Safety Review - ZOFRAN (ondansetron) - Assessing the Potential Harm to the Fetus Health Canada carried out a safety review to assess the risk of birth defects with the use of ondansetron, as part of routine health product monitoring and because this drug is not authorized for sale in Canada to treat nausea and vomiting during pregnancy. The use of ondansetron during pregnancy is not recommended because its safety has not been established in pregnant women. 2024-05-10 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewZOFRANondansetronassessingpotential harm-to-the-Fetus Summary Safety Review - ZOFRAN (ondansetron) - Assessing the Potential Harm to the FetusHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-zofran-ondansetron-assessing-potential-harm-fetus.html Summary Safety Review - ZOFRAN (ondansetron) - Assessing the Potential Harm to the FetusHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/resume-examen-innocuite-zofran-ondansetron-evaluation-risque-potentiel-foetus.html

Health Canada carried out a safety review to assess the risk of birth defects with the use of ondansetron, as part of routine health product monitoring and because this drug is not authorized for sale in Canada to treat nausea and vomiting during pregnancy. The use of ondansetron during pregnancy is not recommended because its safety has not been established in pregnant women.

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