Health Product InfoWatch, February 2020
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
- Health products mentioned in this issue
- Monthly recap
- New information
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and biologics
- Mekinist (trametinib)
- PMS-Nystatin Oral Suspension
- Tafinlar (dabrafenib mesylate)
- Tapazole (methimazole)
Mandatory reporting by hospitals guidance document
On December 16, 2019, new mandatory reporting requirements for hospitals came into force. Under the regulations, hospitals are now required to report to Health Canada all serious adverse drug reactions and medical device incidents within 30 days of being documented at the hospital.
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document provides hospitals with information that may be useful in complying with the regulations. Comments on the guidance document are welcome and any comments received before March 31, 2020, will help to inform document revisions in advance of a formal guidance consultation planned for the fall of 2020.
To comment on the current guidance please contact the Canada Vigilance Program.
Phone: 1-866-234-2345 | Fax: 1-866-678-6789
Monthly recap of health product safety information
The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in January 2020 by Health Canada.
PMS-Nystatin Oral Suspension
Pharmascience Inc. recalled one lot of PMS-Nystatin Oral Suspension, because it may contain clumps or jelly-like material that may pose a choking risk. Newborns, infants and people with difficulty swallowing are particularly at risk.
Advisory – PMS-Nystatin Oral Suspension
Unauthorized health products
Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.
Advisory – Multiple unauthorized health products
Advisory – Unauthorized ZO Medical skin-whitening creams in North York, Ontario
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 pharmaceuticals is available on Health Canada's Product Monograph Brand Safety Updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.
Mekinist (trametinib) and Tafinlar (dabrafenib mesylate)
The risk of severe cutaneous adverse reactions (SCARs) has been included in the Warnings and Precautions and Consumer Information sections of the Canadian product monographs for Mekinist and Tafinlar.
Key messages for healthcare professionals:Footnote 1Footnote 2
- Cases of SCARs, including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during combination therapy with Mekinist and Tafinlar.
- Before initiating treatment, patients should be advised of the signs and symptoms of SCARs and monitored closely for skin reactions. If signs and symptoms suggestive of SCARs appear, Mekinist and Tafinlar should be withdrawn.
- Footnote 1
Mekinist (trametinib) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2019.
- Footnote 2
Tafinlar (dabrafenib mesylate) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2019.
The risk of acute pancreatitis has been included in the Contraindications, Warnings and Precautions, Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monograph for Tapazole.
Key messages for healthcare professionals:Footnote 3
- Tapazole is now contraindicated in patients with a history of acute pancreatitis after administration of methimazole.
- There have been post-marketing reports of acute pancreatitis in patients receiving methimazole.
- In case of acute pancreatitis, Tapazole should be discontinued immediately. Tapazole treatment should not be started in patients with a history of acute pancreatitis that has been attributed to methimazole. Re-exposure may result in recurrence of acute pancreatitis with decreased time to onset.
- Footnote 3
Tapazole (methimazole) [product monograph]. Saint-Laurent (QC): Paladin Labs Inc.; 2019.
This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.
Reporting adverse reactions
Canada Vigilance Program
Fax or mail: Form available on MedEffect Canada
For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.
- MedEffectTM Canada
- Recalls and Safety Alerts Database
- New Safety and Effectiveness Reviews
- Canada Vigilance Adverse Reaction Online Database
- Drug Product Database
- Medical Devices Active Licence Listing
- Licensed Natural Health Products Database
- The Drug and Health Product Register
- Drug Shortages Canada
- Annual trends for adverse reaction case reports and medical device problem incidents
- Stop Illegal Marketing of Drugs and Devices
Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca
Marketed Health Products Directorate
Address Locator 1906C
Ottawa ON K1A 0K9
© 2020 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.
Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.
Due to time constraints relating to the production of this publication, information published may not reflect the most current information.
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