The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.
The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates for brand name pharmaceutical drugs is available on Health Canada's Web site.
The risk of irreversible premature fusion of the epiphyses in pediatric patients* has been added to the Indications and clinical use, Warnings and precautions (boxed Serious Warnings and Precautions), and Adverse Reactions sections of the Canadian product monograph for Erivedge (vismodegib).
Key messages for healthcare professionals:Footnote 1
* Use of Erivedge (vismodegib) in children and adolescents aged below 18 years is contraindicated.
Erivedge (vismodegib) [product monograph]. Mississauga (ON): Hoffmann-La Roche Limited; 2016.
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The risk of lower limb amputation, primarily of the toe, has been added to the Adverse Reactions section of the Canadian product monographs for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride).
† Study details available at https://clinicaltrials.gov/ct2/show/NCT01032629.
Invokana (canagliflozin) [product monograph]. Toronto (ON): Janssen Inc.; 2016.
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Invokamet (canagliflozin and metformin hydrochloride) [product monograph]. Toronto (ON): Janssen Inc.; 2016.
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The risk of agranulocytosis has been included in the Post-Market Adverse Drug Reactions section of the Canadian product monograph for Rythmodan (disopyramide).
Key message for healthcare professionals:Footnote 4
Rythmodan (disopyramide) [product monograph]. Laval (QC): sanofi-aventis Canada Inc.; 2016.
Return to footnote 4 referrer