Health Product InfoWatch – April 2019
- Health products mentioned in this issue
- Announcement: Impurities found in certain angiotensin II receptor blockers
- Monthly recap
- New information
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and Biologics
Extraneal peritoneal dialysis solution
Pro Doc Limitée Irbesartan
Natural Health Products
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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 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
Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca
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© 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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