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:

Your reports and the other information we collect helps us:

Case study examples

The examples in the table show the ways that adverse reaction and medical device problem reports and other information can:

Once we make an assessment, we communicate our decision through various means. These include:

Table 1. Examples of review findings

Adverse Reactions to Drugs
Suspected Product Description of Adverse Reaction/Medical Device Problem Reported Review Findings  Product Safety Information Date of Action Taken

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

Information Update: Health Canada safety review finds possible link between Fibristal and risk of liver injury  

January 11, 2019

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
Product Monograph Update

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

Medical Device Problems
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:

  • hospitals
  • long-term care facilities
  • home care settings

Health Canada reviewed the relevant scientific and legal requirements on medical device regulations for hospital beds. To reduce risks, we:

  • sent safety information to manufacturers, health care professionals and consumers
  • encouraged health care professionals and consumers to report problems
  • monitored problems with hospital beds with bedrails
  • worked with manufacturers to correct identified problems

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

Notice to Hospitals: Risk of entrapment of patients in hospital beds

October 20, 2009

Notice to Hospitals: Risk of Patient Entrapment (update)

August 10, 2012

Web Page: Hospital bed safety

February 20, 2015

Dear Health Care Professional Letter: Risk of patient entrapment

April 7, 2017

Summary Safety Review: Hospital Beds – Assessing the Potential Risk of Patient Entrapment

April 10, 2017

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

Notice: Changes to evidence requirements for Class II and Class III infusion pumps

August 13, 2018

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:

  • to find out whether their machine had been affected
  • to provide the necessary service

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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