Health Product InfoWatch – July 2022
- Health products mentioned in this issue
- Coronavirus disease (COVID-19)
- Drug and vaccine authorizations and communications for COVID-19
- Monthly recap of health product safety information
- New health product safety information
- Safety Brief
- Notice of market authorization with conditions:
- Reporting Adverse Reactions
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and biologics
Albrioza (sodium phenylbutyrate, ursodoxicoltaurine)
Dianeal Peritoneal Dialysis solution
Paxlovid (nirmatrelvir and ritonavir)
Spikevax (COVID-19 Vaccine Moderna)
Succinylcholine Chloride Injection, USP
Topical corticosteroids (prescription)
Natural and non-prescription health products
Coronavirus disease (COVID-19)
For the most up-to-date information on COVID-19, please visit the Government of Canada Coronavirus disease (COVID-19) website Canada.ca/coronavirus, which includes a dedicated section for healthcare professionals, and for the health product industry.
The COVID-19 vaccines and treatments portal provides information for consumers, healthcare professionals and researchers on vaccines and treatments authorized for COVID-19.
For information about adverse events following immunization that individuals have reported after receiving a COVID-19 vaccine in Canada, new safety signals or other safety updates, please visit the COVID-19 vaccine safety in Canada webpage.
Drug and vaccine authorizations and communications for COVID-19
New information and recent communications related to authorized COVID-19 vaccines and treatments are highlighted in this section.
Paxlovid (nirmatrelvir and ritonavir)
A new Paxlovid dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to mitigate dosing errors, given that these patients require a reduced daily dose of nirmatrelvir. Each carton of the new dose pack contains 20 tablets divided in 5 daily-dose blister cards. Each daily blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each), which are separated into morning and evening doses.
When indicated, Paxlovid should be initiated as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of the onset of symptoms.
Spikevax (COVID-19 Vaccine Moderna)
Spikevax was authorized by Health Canada on July 14, 2022 for the extension of the indication to include active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 6 months to 5 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.
Incorrect packaging or labelling of peritoneal dialysis solutions
Health Canada is aware of customer complaints about incorrectly packaged bags of peritoneal dialysis solutions. Baxter Corporation Dianeal Peritoneal Dialysis (PD) 101 Continuous Ambulatory Peritoneal Dialysis (CAPD) solution with a lower concentration of dextrose (1.5%) was reported to be in boxes labelled 2.5% dextrose. An investigation into these complaints suggests that the error did not occur during the manufacturing or controlled packaging processes. No adverse events were reported with these complaints.
Patients and caregivers should be advised to check the individual labels on the dialysis bags before use. Receiving a different concentration of dextrose may compromise safety and efficacy of the dialysis treatment. If a patient or caregiver identifies a packaging or labelling error, they should contact the manufacturer or the distributor immediately to receive the correct product as soon as possible, and so that an investigation can be done to see if other errors may have occurred.
If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed.
Monthly recap of health product safety information
For health product advisories related to COVID-19 vaccines and treatments, please see the Drug and vaccine authorizations and communications for COVID-19 section.
Succinylcholine Chloride Injection, USP
One lot of Succinylcholine Chloride Injection, USP was recalled due to the sterility being out of specification in the affected lot (Periodic Media Fill Validation failure).
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: Unauthorized products may pose serious health risks
Advisory: Unauthorized products may pose serious health risks (March 26, 2021 to June 3, 2022)
Advisory: Unauthorized health products seized from three herbal medicine stores in Calgary, Alberta (Updated June 16, 2022)
New health product safety information
The following topics have been selected to raise awareness and encourage reporting of adverse reactions.
Topical corticosteroids and the risk of topical withdrawal reactions
Topical corticosteroids (TCS) are used for symptomatic treatment of various acute and chronic skin conditions where anti-inflammatory, anti-allergenic and antipruritic activity is required, such as eczema, psoriasis, and contact dermatitis.Footnote 1Footnote 2 TCS have been marketed in Canada since 1954 and are currently available with or without a prescription in various dosage forms (cream, gel, lotion, ointment, shampoo, solution, and spray). Examples of TCS currently authorized in Canada include: amcinonide, betamethasone, clobetasol, clobetasone, desonide, desoximetasone, flumethasone, fluocinolone, fluocinonide, halobetasol, hydrocortisone, mometasone, prednicarbate, and triamcinolone.Footnote 3Footnote 4 TCS are categorized in various potencies (low, moderate, high, and ultra-high) and classes (I to VII) based on the corticosteroid molecule, its strength, and dosage form.Footnote 1
Topical corticosteroid withdrawal reactions have been reported following discontinuation of prolonged, frequent, and/or inappropriate use of mostly moderate to high potency TCS, especially on the face and genital area.Footnote 1Footnote 2Footnote 5Footnote 6 This severe and potentially debilitating reaction, also referred to as "Red Skin Syndrome" or "Topical Steroid Addiction",Footnote 2Footnote 5Footnote 6Footnote 7 is rare. Symptoms have been reported to emerge within days or weeks after discontinuation of long-term TCS treatment and include burning, stinging, and bright red skin that is worse than the pre-treatment condition, followed by flaking and peeling of the skin. It takes anywhere from a few days to several months for the reaction to peak and may take weeks to years for the skin to return to its original condition.Footnote 8 Diagnosis of TCS withdrawal reactions remains challenging given the lack of diagnostic criteria and an overlap in histopathology with a flare-up of the underlying skin disorder upon skin biopsy.Footnote 2Footnote 6Footnote 7
Recently, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) conducted a review of TCS withdrawal reactions.Footnote 2Footnote 7 The majority of cases reviewed by the MHRA were associated with the use of moderate to high potency TCS. However, the MHRA review also included cases of TCS withdrawal reactions associated with the lower potency TCS, hydrocortisone, and ultra-high potency TCS, as well as cases in children. The MHRA review concluded that TCS are safe and effective when used correctly as per the indication and as instructed for treatment of certain skin conditions for short periods of time, or with short breaks in treatment over an extended period.
- A rare but severe form of withdrawal reaction may occur upon discontinuation after prolonged and/or inappropriate use of mostly moderate to high potency TCS.Footnote 1Footnote 2Footnote 5Footnote 6 This reaction can develop after application of a TCS at least daily for longer than a year in adults and within as little as 2 months of daily use in children.Footnote 2 Females and people with atopic dermatitis are thought to be most at risk of developing TCS withdrawal reactions.Footnote 2Footnote 5Footnote 8
- Some distinctive features of TCS withdrawal reactions may include:
- spread of rash and redness to new areas of the skin beyond the initial treatment area,Footnote 2Footnote 6Footnote 7Footnote 8
- shift from itching to burning or stinging of skin,Footnote 2Footnote 5Footnote 6Footnote 7Footnote 8 and
- confluent skin redness rather than patchy (more flushed skin similar to a sunburn).
- Children and infants may be more susceptible to systemic adverse effects of TCS due to proportionally greater absorption because of an immature skin barrier and a greater surface area to body weight ratio compared to adults.Footnote 1Footnote 5Footnote 9
- In order to prevent TCS withdrawal reactions, healthcare professionals are advised to:
- prescribe the lowest potency needed,Footnote 1Footnote 2Footnote 7Footnote 10
- advise patients on the amount and frequency (e.g., once or twice a day) of product to be applied to the affected area,Footnote 1Footnote 2Footnote 7Footnote 9Footnote 10
- inform patients on duration of use, particularly on sensitive areas, e.g., face and genitals,Footnote 2Footnote 5Footnote 7
- switch to a lower potency TCS if treatment beyond the recommended duration of time is necessary,Footnote 2Footnote 7
- taper use or advise periodic breaks in treatment in patients on long-term, continuous TCS treatment,Footnote 9Footnote 9Footnote 9 and
- inform patients to seek medical advice if their skin condition worsens while using TCS or within 2 weeks after stopping the treatment.Footnote 2Footnote 7
- Healthcare professionals are encouraged to report withdrawal reactions suspected of being associated with TCS to the Canada Vigilance Program. This information will support ongoing monitoring of this safety issue.
Health Canada will continue to monitor safety information involving TCS withdrawal reactions to identify and assess potential harms.
- Footnote 1
Corticosteroids: Topical. Canadian Pharmacists Association (CPhA) Monograph [database online]. Updated June 26, 2019. Accessed May 12, 2022. https://www.e-therapeutics.ca/search
- Footnote 2
Drug Safety Update. volume 15, issue 2: September 2021: 1. Topical corticosteroids: information on the risk of topical steroid withdrawal reactions. Medicines and Healthcare products Regulatory Agency (MHRA). September 15, 2021. Accessed April 27, 2022. https://www.gov.uk/drug-safety-update/topical-corticosteroids-information-on-the-risk-of-topical-steroid-withdrawal-reactions
- Footnote 3
Drug Product Database: Health Canada. Updated June 18, 2015. Accessed June 13, 2022.https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
- Footnote 4
Licensed Natural Health Products Database Health Canada. Updated January 4, 2019. Accessed June 13, 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-products-database.html
- Footnote 5
National Eczema Association. Education Announcement: Use of Topical Steroids for Eczema. Topical corticosteroid addiction and withdrawal. Updated July 17, 2021. Accessed April 27, 2022. https://nationaleczema.org/warnings-for-topical-steroids-eczema/
- Footnote 6
Ballard A. TSW: What the Eczema Community Needs to Know, Now. National Eczema Association. March 22, 2021. Updated May 5, 2021. Accessed April 27, 2022. https://nationaleczema.org/tsw-need-to-know/
- Footnote 7
Medicines and Healthcare products Regulatory Agency (MHRA). MHRA Public Assessment Report. Topical steroid withdrawal reactions: a review of the evidence. September 15, 2021. Accessed April 27, 2022. https://www.gov.uk/government/publications/topical-steroid-withdrawal-reactions-a-review-of-the-evidence
- Footnote 8
Topical corticosteroid withdrawal. DermNet NZ. Published February 2016. Accessed April 27, 2022. https://dermnetnz.org/topics/topical-corticosteroid-withdrawal
- Footnote 9
Murray E. Using topical corticosteroids safely and effectively. The University of British Columbia, Faculty of Medicine, Continuing Professional Development. Published October 16, 2019. Accessed May 12, 2022. https://thischangedmypractice.com/topical-corticosteroids/
- Footnote 10
Wong ITY, Tsuyuki RT, Cresswell-Melville A, et al. Guidelines for the management of atopic dermatitis (eczema) for pharmacists. Can Pharm J. (Ott) 2017; 150(5):285-97. doi: 10.1177/1715163517710958
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 type 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. For the most up-to-date information, consult Health Canada's NOC database.
Albrioza (sodium phenylbutyrate, ursodoxicoltaurine): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Albrioza (sodium phenylbutyrate, ursodoxicoltaurine), powder for suspension, 3 g / 1 g sachet, oral. Albrioza is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Patients should be advised of the conditional market authorization for this indication.
For the complete prescribing information and information available for patients/caregivers, please consult the Albrioza Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Amylyx Pharmaceuticals Inc. website or by contacting Amylyx Pharmaceuticals Inc. at 1-877-374-1208. 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 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
- Stop Illegal Marketing of Drugs and Devices
- List of drugs for exceptional importation and sale
- Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications
- Reported side effects following COVID-19 vaccination in Canada
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Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
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©2022 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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