Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis)

Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis) Health Canada reviewed the potential risk of colitis with Aubagio use after finding reports (since being marketed) of colitis as part of routine review of information received from the manufacturer. Also, the product safety information of a closely-related drug, Arava (leflunomide) was updated to include a new warning for colitis. In Canada, the product safety information for Aubagio does not mention the risk of colitis. 2024-05-08 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewAUBAGIO (teriflunomide)assessingpotential riskinflammation of the coloncolitisrisk of colitisproduct safety informationa closely-related drugArava (leflunomide)new-warning for colitis Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/aubagio-assessing-potential-risk-inflammation-colon.html Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/aubagio-evaluation-risque-potentiel-inflammation-colon.html

Health Canada reviewed the potential risk of colitis with Aubagio use after finding reports (since being marketed) of colitis as part of routine review of information received from the manufacturer. Also, the product safety information of a closely-related drug, Arava (leflunomide) was updated to include a new warning for colitis. In Canada, the product safety information for Aubagio does not mention the risk of colitis.

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