Page 2: Health Product InfoWatch – July 2017
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.
Bisphosphonates, oral and injectable
Additional information concerning the risk of osteonecrosis of the jaw (ONJ) has been added to the Warnings and Precautions section of the Canadian product monographs (CPMs) for all oral and injectable bisphosphonates (alendronate, clodronate, etidronate, pamidronate, risedronate and zoledronic acid).
For oral and injectable formulations, the following should be considered when evaluating a patient's risk of developing ONJ:
- Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds).
- Route of administration (higher risk for parenteral administration).
- Cumulative dose of bone resorption therapy.
- Co-morbid conditions (e.g., anemia, coagulopathies) and smoking.
- Periodontal disease, poorly fitting dentures, history of dental disease.
In addition, the following has been added to the CPMs of the injectable formulations:
- The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
- If ONJ occurs while on treatment, temporary interruption should be considered until the condition resolves and contributing risk factors are mitigated where possible.
- Reference 1
Aclasta (zoledronic acid injection) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2017.
- Reference 2
ACT Etidronate (etidronate disodium tablets) and ACT Etidrocal (etidronate disodium tablets and calcium carbonate tablets) [product monograph]. Mississauga (ON): Actavis Pharma Company; 2017.
- Reference 3
Actonel (risedronate sodium tablets) and Actonel DR (risedronate sodium delayed-release tablets) [product monograph]. Mississauga (ON): Warner Chilcott Canada Co.; 2017.
- Reference 4
Bonefos (clodronate disodium capsules and clodronate disodium for injection) [product monograph]. Mississauga (ON): Bayer Inc.; 2017.
- Reference 5
Clasteon (clodronate disodium capsules and clodronate disodium injection) [product monograph]. Mississauga (ON): Sunovion Pharmaceuticals Canada Inc.; 2017.
- Reference 6
Fosamax (alendronate sodium tablets) and Fosavance (alendronate sodium/cholecalciferol tablets) [product monograph]. Kirkland (QC): Merck Canada Inc.; 2017.
- Reference 7
Pamidronate Disodium for Injection (pamidronate disodium) [product monograph]. Kirkland (QC): Hospira Healthcare Corporation; 2017.
- Reference 8
Zometa (zoledronic acid for injection) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2017.
Evotaz (atazanavir and cobicistat) and Reyataz (atazanavir)
The risk of chronic kidney disease has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monographs for Reyataz and Evotaz.
- Chronic kidney disease (CKD) has been reported in patients treated with atazanavir, with or without ritonavir. Some cases resulted in fatal outcomes or requiring hemodialysis.
- Reyataz and Evotaz should be used with caution, particularly in those patients with other risk factors for CKD.
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