Page 2: Health Product InfoWatch - December 2016
New health product safety information
The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.
Product monograph updates
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
- Irreversible premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. Premature fusion can progress after discontinuation of treatment.
- Due to safety concerns, Erivedge is contraindicated in children and adolescents aged below 18 years.
* Use of Erivedge (vismodegib) in children and adolescents aged below 18 years is contraindicated.
Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride)
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).
- In an ongoing cardiovascular study of 4 327 patients with type 2 diabetes, with known or at high risk for cardiovascular disease, the incidence rates of lower limb amputation, primarily of the toe, were 7.3, 5.4 and 3.0 per 1 000 patient years of exposure to canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, with the imbalance occurring as early as the first 26 weeks of therapy.
- In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetes population of 8 111 patients, no difference in lower limb amputation risk was observed relative to control.
Study details available at https://clinicaltrials.gov/ct2/show/NCT01032629.
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
- There have been post-marketing cases of agranulocytosis in patients receiving Rythmodan.
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