Health Product InfoWatch: January 2026

Contents

• Monthly recap of health product safety information
  • Dimethyl fumarate-containing products
  • FreeStyle Libre 3 Plus Sensor Kit
  • Unauthorized health products
  • Yescarta (axicabtagene ciloleucel)
• New health product safety information
  • Safety briefs
    • Potential risks of radiofrequency microneedling
    • The use of some natural health products and the potential risk of hepatotoxicity
  • Notice of market authorization with conditions
    • Wegovy (semaglutide): Authorization with conditions
• Scope
• Reporting Adverse Reactions
• Helpful links
• Contact us

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and select medical device recalls, and summaries of completed safety reviews published in December 2025 by Health Canada.

Dimethyl fumarate-containing products

This safety review evaluated the risk of gastrointestinal events of perforation, ulceration, hemorrhage and obstruction with the use of dimethyl fumarate. Health Canada's review found a possible link. Health Canada will update the Canadian product monographs for all dimethyl fumarate-containing products to include the risk of gastrointestinal events of perforation, ulceration, hemorrhage and obstruction.

Summary Safety Review: Dimethyl fumarate-containing products

FreeStyle Libre 3 Plus Sensor Kit

Affected lots of FreeStyle Libre 3 Plus Sensor Kits have been recalled as they may provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

Type II medical device recall: FreeStyle Libre 3 Plus Sensor Kit

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: Unlicensed Chroma D-Light UV lamp
Advisory: Unauthorized health products seized from two stores in Maple Ridge, BC
Advisory: Unauthorized health products sold online and seized at Rize Fitness

Yescarta (axicabtagene ciloleucel)

Cerebral edema is a known risk of chimeric antigen receptor (CAR) T-cell therapy and is described in the Yescarta Canadian product monograph. Patients being treated with Yescarta for primary mediastinal B-cell lymphoma may be at increased risk for developing cerebral edema, including fatal events, compared to other large B-cell lymphomas.

Health Product Risk Communication: Yescarta (axicabtagene ciloleucel)

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Safety briefs

Potential risks of radiofrequency microneedling

Radiofrequency (RF) microneedling is a dermatologic or aesthetic procedure using a medical device that combines two techniques: microneedling and the use of RF energy. Through the use of ultrafine needles, RF microneedling creates controlled micro-injuries in the skin while simultaneously delivering RF energy into deeper layers of the skin. The intended use of these medical devices is to improve the appearance of the skin.

In Canada, medical devices are classified into one of four classes, where Class I represents the lowest risk and Class IV the highest. RF microneedling devices licensed by Health Canada are considered Class III, and can be found on Health Canada’s Medical devices active licence listing webpage.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication for potential risks including burns, scarring, fat loss, disfigurement, and nerve damage associated with certain uses of RF microneedling.

While reports of incidents in Canada are limited, given these potential risks, Health Canada is recommending that healthcare professionals remain vigilant, and report any incidents or complications suspected of being associated with RF microneedling to support continued monitoring.

The use of some natural health products and the potential risk of hepatotoxicity

Natural health products (NHPs) are widely used across Canada and can be perceived by some consumers as safe or harmless.^{Footnote 1Footnote 2} However, although rare, some NHPs have been suspected of being associated with serious adverse reactions, including hepatotoxicity, and cases continue to be reported in Canada and internationally.

Hepatotoxicity from NHP use is not well characterized as it may be hepatocellular, cholestatic or mixed.^{Footnote 2Footnote 3} The etiology is generally considered idiosyncratic.^{Footnote 4Footnote 5} Many adverse reaction reports involve multiple NHPs or provide insufficient information, limiting clarity on specific ingredients.^{Footnote 2Footnote 3}

Common symptoms of hepatotoxicity from NHP use are often non-specific and can differ in severity. Symptoms can include fatigue, nausea and vomiting, loss of appetite, jaundice, dark urine, pale stools, pruritus, right upper quadrant abdominal pain, fever, rash, or elevated liver enzymes.^{Footnote 3Footnote 5Footnote 6} In addition, severe or late symptoms may include hepatic encephalopathy, coagulopathy, ascites or edema. Although most cases are asymptomatic and often resolve with the discontinuation of the suspected product(s), the outcomes of hepatotoxicity from NHP use can vary.^{Footnote 7Footnote 8} In rare cases, the use of certain NHPs has been associated with more serious outcomes such as liver transplantation or death.^{Footnote 2}

Health Canada has previously reviewed and/or communicated on the safety of Aloe vera, Artemisia annua, black cohosh, green tea extract, Pelargonium species, and Polygonum species in relation to the risk of hepatotoxicity.^{Footnote 9Footnote 10Footnote 11Footnote 12Footnote 13}

More recently, Health Canada reviewed Canadian and international evidence supporting a possible link between the use of NHPs containing Garcinia gummi-gutta or hydroxycitric acid, as well as those containing turmeric or curcuminoids^{Footnote *} for oral use, and the risk of hepatotoxicity. Health Canada has updated the relevant monographs to include information on this risk. Health Canada expects that licence holders update this risk information on impacted product labels.

While the use of NHPs continues to grow, adverse events still often go unreported.^{Footnote 2Footnote 3} Reporting suspected cases of hepatotoxicity to Health Canada will help the department monitor safety and identify emerging risks.

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.

Wegovy (semaglutide): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the NOC/c policy, for a new indication for Wegovy^{Footnote †} (semaglutide), a solution for subcutaneous injection in a single use or multi-use pre-filled pen. The new indication for Wegovy is for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). 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 Wegovy Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the Novo Nordisk Canada Inc. website or by contacting Novo Nordisk Canada Inc. at 1-800-465-4334. 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

• MedEffect™ Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• Canada Vigilance Adverse Reaction Online Database
• Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Medical Devices Active Licence Listing
• Licensed Natural Health Products Database
• The Drug and Health Product Portal
• Drug Shortages Canada
• Medical Device Shortages
• COVID-19 Vaccines and Treatments Portal

Contact us

Your comments are important to us. Let us know what you think by reaching us at: infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9