Health Product InfoWatch – April 2019

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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 190000

Published: 2019-04-25

Health products mentioned in this issue
Announcement: Impurities found in certain angiotensin II receptor blockers
Monthly recap
New information
- Notice of market authorization with conditions: Libtayo (cemiplimab)
Scope
- Reporting Adverse Reactions
Helpful links
Suggestions?
Copyright

Health products mentioned in this issue

Announcement

Impurities found in certain angiotensin II receptor blocker products, also known as sartans

Health Canada has published a complete list of angiotensin II receptor blocker (ARB) products recalled in Canada due to the presence of or the potential for nitrosamine impurities. This list will be updated if new products are recalled.

Health Canada has also posted results of sample testing of ARBs on the Canadian market for N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).

Health Canada continues to work closely with international regulatory partners to share information and coordinate efforts on inspections, risk assessments and public communications and will continue to take action and update Canadians should any new risks be identified for products on the Canadian market.

For full information on sartan recalls as well as Heath Canada testing results please visit Health Canada’s sartan Web page.

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 March 2019 by Health Canada.

Darzalex (daratumumab)

Cases of hepatitis B virus (HBV) reactivation, some with a fatal outcome, have been reported in patients treated with Darzalex. Healthcare professionals are advised to: perform HBV screening in all patients before starting Darzalex treatment; monitor patients with evidence of positive HBV serology for clinical and laboratory signs of HBV reactivation; and suspend Darzalex, any concomitant steroids and chemotherapy treatment in patients who develop reactivation of HBV and start appropriate treatment. Health Canada is currently working with the manufacturer to include the risk of HBV reactivation in the Darzalex Canadian product monograph.

Health Professional Risk Communication – Darzalex

Extraneal peritoneal dialysis solution

Two lots of Extraneal peritoneal dialysis solution were recalled as a precautionary measure because of high levels of sodium hydroxide. Use of the affected product in patients could cause chemical peritonitis. The lots affected by this recall were distributed by Baxter between March 14, 2019 and March 20, 2019.

Advisory – Extraneal peritoneal dialysis solution
Drug recall – Extraneal peritoneal dialysis solution

Homeopathic remedies

Health Canada is concerned about false claims being made in some marketing of homeopathic remedies, known as nosodes, stating that the product can prevent infectious diseases. Nosodes are not, and never have been, approved by Health Canada to be vaccine alternatives.

Information Update – Homeopathic remedies

Losartan-containing drugs

Multiple lots of losartan-containing drugs were recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc Limitée because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). NMBA is potentially a human carcinogen.

Information Update – Losartan-containing drugs
Sartan recalls and testing

Opsumit (macitentan)

This safety review evaluated the risk of liver injury associated with Opsumit (macitentan). Health Canada's review concluded that there may be a link. Health Canada will notify the manufacturer to update the Canadian product monograph for Opsumit to inform healthcare professionals and patients about the potential for liver injury.

Summary Safety Review – Opsumit (macitentan)

Pro Doc Limitée Irbesartan

Pro Doc Limitée recalled 2 lots of irbesartan tablets because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The lots were distributed in Quebec only. NDEA is classified as a probable human carcinogen. Pro Doc Limitée is conducting the recall after testing identified levels of NDEA above what is considered reasonably safe if the drug were taken over a lifetime.

Information Update – Pro Doc Limitée Irbesartan
Sartan recalls and testing

Tecentriq (atezolizumab)

Cases of immune-related myositis, some with a fatal outcome, have been reported in patients receiving Tecentriq (atezolizumab). Healthcare professionals are advised to: hold Tecentriq treatment in patients with moderate or severe immune-related myositis until symptoms resolve; permanently discontinue Tecentriq treatment in patients with recurrent, severe, or life-threatening myositis; and administer corticosteroids to patients who develop severe signs of myositis. For patients with severe or life-threatening myositis who do not improve following corticosteroid therapy, consider administration of other immunosuppressive agents. Health Canada is working with the manufacturer to include the risk of immune-related myositis in the Tecentriq Canadian product monograph.

Health Professional Risk Communication – Tecentriq (atezolizumab)

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
Information Update – Plasma pens

Xeljanz, Xeljanz XR

Health Canada is conducting a safety review after issues were discovered during a clinical trial involving rheumatoid arthritis patients being treated with Xeljanz/Xeljanz XR (tofacitinib). The ongoing clinical trial found an increased risk of blood clots in the lungs and of death when the drug was taken at a high dose of 10 mg twice a day. Patients who were taking 10 mg of tofacitinib twice a day are now transitioning to the lower, currently authorized dose of 5 mg twice a day. Health Canada is working with Pfizer to evaluate the available safety information for tofacitinib and will inform the public of any new safety findings as needed, once the review is complete.

Information Update – Xeljanz, Xeljanz XR

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.

Notice of market authorization with conditions

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the nature of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada, in accordance with the NOC/c Policy. For the most up-to-date information, consult Health Canada's NOC database.

Libtayo (cemiplimab): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy, for Libtayo (cemiplimab) concentrate for solution for infusion (50mg/mL). Libtayo is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Patients should be advised about the conditional market authorization for this indication.

For the complete prescribing information and information available for the patients/caregivers, please consult the Libtayo Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the sanofi-aventis Canada Web site or by contacting sanofi-aventis Canada Inc. at 1-800-265-7927. Contact the company for a copy of any references, attachments or enclosures.

Scope

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
Telephone: 1-866-234-2345
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.

Helpful links

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca

Health Canada
Marketed Health Products Directorate
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

© 2019 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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Date modified:: 2022-07-04

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