Case study on adverse reactions to drugs and problems with medical devices
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Background
All health products carry risks and benefits. Consumers, industry, hospitals and health care providers are encouraged to report side effects (adverse reactions) and problems with medical devices to Health Canada.
We assess these reports and review published scientific literature and information submitted to us by:
- market authorization holders (manufacturers, licence holders, importers, distributors)
- foreign regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency
Your reports and the other information we collect helps us:
- identify potential safety issues
- undertake regulatory actions, such as removing a product from the Canadian market
- identify previously unrecognized rare or serious adverse reactions or medical device problems
- add to international data on the benefits, risks or effectiveness of drugs, natural health products and medical devices
- communicate changes in product safety information to consumers, industry, hospitals and health care providers
Case study examples
The examples in the table show the ways that adverse reaction and medical device problem reports and other information can:
- trigger the review process
- help identify a new safety issue
Once we make an assessment, we communicate our decision through various means. These include:
- advisories
- fact sheets
- guidance documents
- summary safety reviews
- Health Product InfoWatch
- health product risk communications (notices to hospitals, dear health care professional letters)
Table 1. Examples of review findings
Suspected Product | Description of Adverse Reaction/Medical Device Problem Reported | Review Findings | Product Safety Information | Date of Action Taken |
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Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs) [Sunitinib (Sutent®), sorafenib (Nexavar®), axitinib (Inlyta®), pazopanib (Votrient®), ponatinib (Iclusig®), regorafenib (Stivarga®), vandetanib (Caprelsa®), lenvatinib (Lenvima®)] |
Artery dissections and artery aneurysms |
The findings identified the need for Health Canada to work with the product manufacturer to update the product safety information of all VEGFR TKIs. The updated product safety information to be published on InfoWatch |
Summary Safety Review: Vascular endothelial growth factor receptor tyrosine kinase inhibitors |
December 2018 |
Fibristal ® (ulipristal) |
Liver injury |
The findings identified the need for Health Canada to work with the product manufacturer to change the label for Fibristal®. The label change advises Canadians of rare cases of liver injury, including serious liver impairment requiring liver transplants. A recommendation was made to monitor liver function before, during and after stopping treatment. |
Summary Safety Review: Fibristal (5 mg ulipristal acetate) |
September 2018 |
Product Monograph Update |
January 2018 |
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Information Update: Health Canada safety review finds possible link between Fibristal and risk of liver injury |
January 11, 2019 |
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Methadone [Methadone®, Metadol-D®] |
Serious harm in children breastfed by mothers receiving methadone treatment |
The findings identified the need for Health Canada to work with the product manufacturer to strengthen product information. We updated the information to warn of the risk of serious harm, including death, in children exposed to methadone through breast milk. |
Summary Safety Review: METHADOSE and METADOL-D |
August 2018 |
Soliris®/Bexsero® |
Increased risk of anemia in patients being treated with Soliris®and vaccinated with Bexsero® |
The findings identified the need for Health Canada to work with the manufacturer to change the label for Soliris®. The label change warns of the risk of anemia if patients are vaccinated when the Soliris® concentration in the blood is considered to be low. The manufacturer implemented the label change worldwide. |
Summary Safety Review: Soliris and Bexsero |
September 2016 |
Product Monograph Update |
December 2015 |
Suspected Product | Description of Adverse Reaction/Medical Device Problem Reported | Review Findings | Product Safety Information | Date of Action Taken |
---|---|---|---|---|
Hospital Bed Rails |
Patient injury and death related to the use of hospital beds or bed rails in:
|
Health Canada reviewed the relevant scientific and legal requirements on medical device regulations for hospital beds. To reduce risks, we:
|
Guidance Document: Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards |
March 17, 2008 |
Fact Sheet: Bed Rails in Hospitals, Nursing Homes and Home Health Care |
June 26, 2008 |
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Notice to Hospitals: Risk of entrapment of patients in hospital beds |
October 20, 2009 |
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Notice to Hospitals: Risk of Patient Entrapment (update) |
August 10, 2012 |
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Web Page: Hospital bed safety |
February 20, 2015 |
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Dear Health Care Professional Letter: Risk of patient entrapment |
April 7, 2017 |
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Summary Safety Review: Hospital Beds – Assessing the Potential Risk of Patient Entrapment |
April 10, 2017 |
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BD Disposable Syringes |
Reduced drug potency due to an interaction of some drugs with certain types of rubber stoppers in these syringes |
In consultation with Health Canada, the manufacturer communicated this issue to customers on August 31, 2015. Following ongoing monitoring, Health Canada issued a risk communication outlining recommendations. |
Dear Health Care Professional Letter: Disposable syringes and reduced drug potency issues |
September 23, 2015 |
Disposable Syringes |
Reports by hospitals of confusion over use of disposable syringes and different labelling from different companies |
Health Canada worked with manufacturers of disposable plastic syringes marketed in Canada to update labelling to align with their intended use. |
Health Product InfoWatch Safety Brief: Disposable plastic syringes |
May 25, 2017 |
CADD Solis Ambulatory Infusion Pumps and CADD Administration Sets |
Infusion inaccuracies or air-in-line |
Health Canada issued recalls of CADD administration sets and CADD Solis infusion pumps following concerns about delivery accuracy. Our post-market review of infusion pumps led to new and amended medical device licence application requirements. |
Medical Device Recall: CADD administration sets with flow stop |
May 5, 2016 |
Medical Device Recall: CADD Solis VIP infusion pumps |
June 11, 2018 |
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Notice: Changes to evidence requirements for Class II and Class III infusion pumps |
August 13, 2018 |
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Bellco Formula Dialysis Machines |
Possible fire hazard |
Health Canada issued an advisory for consumers to be vigilant. We also recommended that they contact their health care providers who administer dialysis:
Consumers were advised to report health product complaints to Health Canada. |
Advisory: Possible fire hazard with Formula kidney dialysis machines manufactured by Bellco |
October 20, 2016 |
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