Health Product InfoWatch – June 2017
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
- Announcement: Mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions
- Monthly recap
- New information
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Aranesp (darbepoetin alfa)
- Erwinase (Erwinia L-asparaginase)
- Mifegymiso (mifepristone and misoprostol tablets)
- Sodium chloride injection 0.9%, USP
- Sustiva (efavirenz)
- Tramacet (tramadol and acetaminophen)
- Xalkori (crizotinib)
Mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions
On June 28, 2017, Health Canada released a consultation paper on mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.
A Webinar will be held on July 18, 2017 at 12:30 pm to share information on the proposed approach for the regulations. To participate, please send your name and email address by Wednesday, July 12 to: MHPD-stakeholders_intervenants-DPSC@hc-sc.gc.ca. Questions may be sent in advance to be answered by Health Canada during the session.
Health Canada is seeking feedback on the consultation paper by August 11, 2017.
Monthly recap of health product safety information
Aranesp (darbepoetin alfa)
Severe and life-threatening skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients treated with Aranesp. Healthcare professionals are advised to discontinue Aranesp therapy immediately if a severe skin reaction occurs or SJS/TEN is suspected and to permanently discontinue Aranesp if SJS/TEN is confirmed. Health Canada is currently working with the manufacturer to include this safety information in the Canadian product monograph.
Erwinase (Erwinia L-asparaginase)
To help manage the impact of the ongoing shortage of Erwinase, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-181G for use with a 5 micron filter. Products with visible particulate matter anywhere other than on the underside of the stopper (e.g., on or in the product) before or after reconstitution, should not be administered. If there is no visible particulate matter in the product after reconstitution, a standard 5 micron filter should be used as an additional precaution.
Foreign health products
These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. The products are not authorized for sale in Canada and have not been found in the Canadian marketplace but it is possible they may have been brought into the country by travellers or purchased over the Internet.
This safety review evaluated the risk of inaccurate temperature readings in children under 2 years old associated with the use of infrared thermometers (IR). Health Canada's review concluded that there is new information to show that ear and forehead contact IR thermometers are appropriate for use in children under 2 years old. Not enough information was available for non-contact IR thermometers, therefore this type is not recommended for use in children under 2 years old.
Mifegymiso (mifepristone and misoprostol tablets)
Celopharma, in collaboration with Health Canada, communicated to healthcare professionals to clarify the different requirements and steps to follow to prescribe, order, stock and/or dispense Mifegymiso, as outlined in the Distribution and Administration Program for Mifegymiso.
Sodium chloride injection 0.9%, USP
Three lots of 0.9% sodium chloride injection USP, 1000 mL were recalled by Fresenius Medical Care Canada due to the potential for leakage of the interior solution bag (lot numbers 16EU05011, 16EU05012, 16EU05013). The affected lots should not be used. Home hemodialysis programs should notify patients in their program about this recall without delay.
- Health Product Risk Communication - Sodium chloride injection 0.9%
- Drug Recall - Sodium chloride injection 0.9%
SynchroMed II - Programmable Pump
This type I recall was an update to information previously communicated to healthcare professionals regarding the failure rate for reduced battery performance in Medtronic Model 8637 SynchroMed II pumps manufactured through June 2011. These affected products have a potential for sudden loss of therapy due to reduced battery performance from the formation of a resistive film. Performance monitoring of the affected pump population has found a higher-than-predicted failure rate in a subset of pumps manufactured between January 2011 and June 2011. This notification does not apply to SynchroMed II devices currently being marketed or implanted, or to any previously implanted devices manufactured after June 2011.
Unauthorized health products
Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online.
- Advisory – Black Mamba 2 Premium and ExtenZe
- Advisory – Dust Extreme
- Advisory – High By Nature
- Advisory – L-tryptophan and lithium orotate products
- Advisory – Poppers and sexual enhancement products
- Advisory – Super Panther 7K and Triple Green
- Update – Poppers and sexual enhancement products
- Update – Sexual enhancement products
This safety review evaluated the risk of gastrointestinal perforation associated with Xalkori (crizotinib). Health Canada's review did not establish a link. Health Canada will continue to monitor the situation.
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