Health Product InfoWatch - March 2017
ISSN 2368-8025
Pub. no 160256
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Contents
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Avastin (bevacizumab)
- Bisphosphonates
- Capsaicin topical
- Cophylac Drops (normethadone and p-hydroxyephedrine)
- Erwinase (Erwinia L-asparaginase)
- Low molecular weight heparins
- Menthol topical
- Methyl salicylate topical
- PMS-Propofol
- Topical pain relievers
- Tramadol-containing products
Medical Devices
- Colorectal stents
- Esophageal stents
- Essure Permanent Birth Control System
- LivaNova Stöckert 3T Heater-Cooler Device
Other
Announcement
Public reporting of drug shortages now mandatory
Regulations came into force this month requiring drug companies experiencing shortages and discontinuances to publicly report them. Drug manufacturers are now required to report on www.drugshortagescanada.ca:
- an anticipated drug shortage 6 months in advance
- a planned discontinuation of a drug 6 months in advance
- any unanticipated shortage or discontinuation within 5 days of learning about it, if less than 6 months in advance
As part of the regulations, a new, independent Web site, www.drugshortagescanada.ca, replaces the industry-run Web site, www.drugshortages.ca, where manufacturers have been voluntarily reporting drug shortages and discontinuances since 2012. The new Web site features enhanced notification features and a mobile application. As well, it provides updated information for healthcare providers and patients, including tools and guidance to help manage shortages.
Monthly recap of health product safety information
The following is a list of health product advisories as well as summaries of completed safety reviews published in February 2017 by Health Canada.
Bisphosphonates
This safety review evaluated the risk of osteonecrosis beyond the area of the jawbone associated with bisphosphonates [alendronate (Fosamax and Fosavance), clodronate (Clasteon and Bonefos), etidronate (Didronel and Didrocal) and risedronate (Actonel, Actonel DR and Actonel Plus Calcium)]. The Canadian product monographs for some of the bisphosphonate-containing products already include warnings about the risk of bone damage in the outer ear canal and/or other bones of the body. Health Canada's review of the available information did not establish a link between the use of the other bisphosphonates and the risk of osteonecrosis of the external ear canal or other parts of the body other than the jaw. Health Canada will continue to monitor the safety of bisphosphonates.
Colorectal stents and Avastin (bevacizumab)
This safety review evaluated the increased risk of intestinal perforation associated with the concurrent use of colorectal stents and bevacizumab. Health Canada's review concluded that there is limited evidence at this time suggesting an increased risk of intestinal perforation when colorectal stents and bevacizumab are used together. Health Canada has also communicated this information to healthcare professionals.
Erwinase (Erwinia L-asparaginase)
Small amounts of particulate matter have been observed bound to the stopper and/or present on the lyophilized cake of some vials of Erwinase from BATCH 180G. Vials of Erwinase with visible particulate matter must not be administered. To avoid potential shortage, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-180G. If there is no visible particulate matter after reconstitution, a standard 5-micron filter needle should be used to withdraw the reconstituted product from the vial prior to administration as an additional precaution. Healthcare professionals should refer to the Erwinase Canadian product monograph for prescribing information.
LivaNova Stöckert 3T Heater-Cooler Device
Stöckert 3T heater-cooler devices manufactured by LivaNova prior to September 2014 are at an increased risk of contamination with Mycobacterium chimaera, a type of nontuberculous mycobacterium, and should be removed from service. If it is not possible to remove these devices from service, facilities should consider interim risk mitigation measures.
Low molecular weight heparins
This safety review evaluated the risk of spinal/epidural hematoma associated with low molecular weight heparins (LMWH). Health Canada's review concluded that the risk of bleeding may increase if the spinal procedure is carried out soon after injection of LMWH. Health Canada requested that the manufacturers of LMWH update the Canadian product monographs to include information on the recommended length of time between LMWH injection and spinal/epidural anaesthesia or spinal puncture.
Over-the-counter topical pain relievers containing menthol, methyl salicylate or capsaicin
This safety review evaluated the risk of serious skin burns associated with over-the-counter topical pain relievers containing menthol, methyl salicylate or capsaicin. Health Canada's review of the available information has established a link between the use of topical pain relievers containing menthol and the risk of rare but serious skin burns; however, there was not enough information to draw the same conclusions for the products containing methyl salicylate or capsaicin alone. Health Canada is updating the labelling standard for all topical pain relievers containing menthol alone or in combination, to inform consumers about this potential risk. Health Canada has also communicated this information to Canadians.
PMS-Propofol
PMS-Propofol 10 mg/mL emulsion (lots or serial numbers A051131 and A060199) has been recalled by Pharmascience Inc. due to contamination by foreign particles (type I recall). The product was distributed to wholesalers and pharmacies in Canada.
Tramadol-containing products
This safety review evaluated the risk of respiratory depression in children and adolescents associated with tramadol-containing products (Durela, Ralivia, Tramacet, Tridural, Ultram, and Zytram XL). Health Canada's review found evidence to show that CYP2D6 ultra-rapid metabolizers are at an increased risk of life-threatening respiratory depression. The review found limited information regarding respiratory depression with the use of tramadol in children. The Canadian product monographs for tramadol-containing products have been updated to include information on tramadol and respiratory depression in CYP2D6 ultra-rapid metabolizers. Health Canada has also communicated this information to healthcare professionals.
Unauthorized health products
Health Canada advised Canadians that it seized various unauthorized health products promoted as workout, weight loss and dietary supplements from Atomik Nutrition in Châteauguay, QC. The products are labelled to contain various drugs, including prescription and controlled drugs, which may pose serious risks.
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