Health Product Insights: Overview for September 2024

Announcement

Reminder: Reporting Adverse Reactions to Cannabis

The effectiveness of Health Canada’s oversight regarding health and safety concerns related to cannabis products, whether for medical or recreational use, relies significantly on the reporting of adverse reactions by healthcare professionals, consumers, and license holders. Both healthcare professionals and consumers are urged to notify Health Canada of any adverse reactions associated with cannabis, irrespective of its purpose. According to the Cannabis Regulations, license holders who market or distribute cannabis products are mandated to report all serious adverse reactions to Health Canada.

Approximately 40% of reports regarding adverse reactions involving cannabis as a suspected substance originated from healthcare professionals. These reports assist Health Canada to:

Detect rare or serious side effects or issues related to cannabis products
Pinpoint possible health risks associated with cannabis products for Canadians
Enhance international data on cannabis product safety available for Canadian consumers
Disseminate new risks related to cannabis products to industry stakeholders, hospitals, healthcare professionals, and consumers promptly
Implement regulatory measures such as altering product labels or withdrawing products from the market to address identified risks.

Guidelines for Reporting Adverse Reactions for Cannabis Products

To aid Health Canada in adequately assessing reported adverse reactions, submissions should ideally contain the following details:

Product details (brand name, license holder, THC and/or CBD content, additional ingredients; purchase location and date)
Usage specifics, including amount, frequency, duration of use (including start and stop dates, as well as method(s) of administration)
Any other suspect products (if applicable)
Concurrent health products or other substances
Patient’s medical background, including whether they were new to cannabis, prior exposure to the suspected product, and any known allergies or sensitivities
Details of the adverse reaction, including onset and duration
Severity of the adverse reaction and justification for its seriousness
Any dechallenge/rechallenge information
Outcome of the adverse reaction

Adverse reactions related to cannabis should be reported to Health Canada, even if specific data is lacking, and regardless of how the cannabis was procured. This is crucial for incidents involving vulnerable groups, like children and the elderly, as well as for cases of interest such as vaping-related lung issues or cannabis-drug interactions.

Health Canada expresses gratitude to all those contributing to the reporting of cannabis-related adverse reactions. Your submissions have provided vital insights aiding ongoing safety assessments of cannabis products.

For inquiries about this communication or adverse reaction reporting, reach out via cannabis_oss-cannabis_bss@hc-sc.gc.ca.

Additional Cannabis Resources

Summary of Health Product Safety Information

Here is a list of health product advisories, type I drug recalls, and summaries of completed safety assessments published by Health Canada in August 2024.

ACH-Sitagliptin

Certain batches of ACH-Sitagliptin (25 mg, 50 mg, and 100 mg) were recalled due to potential exceedance of the acceptable intake limit for the nitrosamine impurity 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine (NTTP).

Breast Implants

This safety assessment looked into the risk of breast implant illness (BII) representative symptoms and diseases in individuals with breast implants. The findings indicate that BII symptoms and diseases have been reported across all implant categories, irrespective of size, shape, fill, or surface texture. The exact relationship between these risks and breast implants remains uncertain. To help with informed choice, information on BII symptoms and diseases has been made available on the breast implant website. Health Canada will persist in monitoring this potential risk.

Epinephrine Injection USP, 1 mg/10 mL Single-Use Syringes

Due to a shortage of Epinephrine Injection USP, 1 mg/10 mL single-use syringes in Canada, Health Canada has permitted the temporary importation and sale of US-authorized Epinephrine Injection USP, 1 mg/10 mL single-dose pre-filled syringes with English-only labeling by Amphastar Pharmaceuticals, Inc. Notably, there are differences in the method of administration between these products, which is crucial in emergency scenarios.

Health First Ashwagandha Supreme Capsules

Health First Network has recalled a batch of Health First Ashwagandha Supreme bottles containing 120 capsules due to a mislabeling as “Dairy Free,” even though the product came into contact with dairy during production, posing serious risks to individuals with severe dairy allergies.

JAMP Digoxin

JAMP Pharma Corporation recalled specific lots of JAMP Digoxin 0.0625 mg and 0.125 mg tablets as some bottles may contain tablets that are either heavier or lighter than specified while appearing normal. Patients may inadvertently receive an incorrect dose.

JAMP-Mycophenolate

JAMP Pharma Corporation recalled all lots of JAMP-Mycophenolate 250 mg capsules due to some capsules possibly weighing more or less than they should, resulting in unintentional dose discrepancies for patients.

Ratio-Ectosone (TEVA-Ectosone) 0.1% Regular Lotion and 0.05% Mild Lotion

Teva Canada Ltd. has broadened its recall to all lots of ratio-Ectosone (TEVA-Ectosone) 0.1% regular lotion and ratio-Ectosone (TEVA-Ectosone) 0.05% mild lotion, following tests that revealed the impurity, betamethasone enol aldehyde, exceeding acceptable limits in additional batches. Furthermore, the products have been recalled due to labeling mistakes, including incorrect dosing instructions.

Sensorcaine with Epinephrine (Bupivacaine Hydrochloride, 5 mg/mL and Epinephrine (Epinephrine Bitartrate), 5 mcg/mL)

In light of the severe shortage of Sensorcaine with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL), Health Canada has allowed the exceptional, temporary importation and sale of Danish-authorized Marcain-Adrenalin (bupivacaine hydrochloride, 5 mg/mL, and adrenaline (adrenaline tartrate), 5 mcg/mL) with Danish-only labels by Aspen Pharmacare Canada Inc. Important differences in product labeling between the Danish and Canadian authorized products should be noted.

Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors (Canagliflozin, Dapagliflozin, Empagliflozin)

This safety assessment reviewed risks of prolonged or incident diabetic ketoacidosis (DKA) in adult patients with type 2 diabetes using SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin). Health Canada’s examination of existing data could not dismiss a potential drug class effect concerning the risk of prolonged DKA. Additionally, several instances of incident DKA in type 2 diabetes patients post-surgery, during which SGLT2 inhibitor treatment was briefly paused, were noted. Health Canada is collaborating with manufacturers to modify the Canadian product monograph for SGLT2 inhibitors to feature a warning about this risk and a suggestion for temporary treatment pauses before surgical procedures.

Unauthorized Health Products

Health Canada has alerted Canadians about numerous unauthorized health products sold in retail settings throughout Canada or online that may carry substantial health risks.

New Health Product Safety Information

This section highlights topics aimed at increasing awareness and promoting the reporting of adverse reactions.

Product Monograph Update

The following safety labeling update to a Canadian product monograph is available for your awareness. A complete compilation of safety labeling updates for pharmaceuticals can be found on Health Canada’s Product Monograph Brand Safety Updates page. Access Canadian product monographs through Health Canada’s Drug Product Database.

Mounjaro (Tirzepatide)

The Warnings and Precautions, Adverse Reactions, and Patient Medication Information sections of the Canadian product monograph for Mounjaro have been modified to include the risk of malnutrition.

Key Messages for Healthcare Professionals:^{Footnote 1}

Malnutrition has been noted in patients using Mounjaro, with some cases being severe, serious, or even fatal.
It is advisable to consider nutritional guidance and supplementation for patients on Mounjaro.
Discontinuation may be needed in cases of severe or ongoing malnutrition.

Scope

This monthly publication is primarily designed for healthcare professionals and includes pertinent information on pharmaceuticals, biologics, medical devices, and natural health products. It summarizes critical health product safety information released in the previous month by Health Canada, as well as a selection of new safety data intended to raise awareness. The fresh information presented is not exhaustive but highlights clinically significant items that warrant broader dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or Mail: Form available on MedEffect Canada

For further details on reporting an adverse reaction, please check the Adverse Reaction and Medical Device Problem Reporting page.

Helpful Links

Contact Us

Your feedback is valuable. Share your thoughts by contacting 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