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

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Publisher-reported update

2024-05-08

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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