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.

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Title (French)	Résumé de l’examen de l’innocuité - AUBAGIO (tériflunomide) - Évaluation du risque potentiel d’inflammation du côlon (colite)
Update Frequency	as_needed
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
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Open Canada Date Published	2017-06-28 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["Résumé de l'examen de l'innocuité", "AUBAGIO (tériflunomide)", "évaluation", "risque potentiel", "inflammation du côlon", "colite", "risque de colite", "informations sur la sécurité du produit", "un médicament étroitement apparenté", "Arava (léflunomide)", "nouvel avertissement concernant la colite"], "en": ["Summary Safety Review", "AUBAGIO (teriflunomide)", "assessing", "potential risk", "inflammation of the colon", "colitis", "risk of colitis", "product safety information", "a closely-related drug", "Arava (leflunomide)", "new-warning for colitis"]}
Open Canada Collection	publication
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