Health Product InfoWatch: August 2024

Contents

• Monthly recap of health product safety information
  • CPAP and BiLevel PAP machines and mechanical ventilators
  • Homemade sunscreens
  • Mega 2000 and Mega Soft Patient Return Electrodes
  • Naloxone Take Home Kits by Canadian Hospital Specialties Ltd.
  • Unauthorized health products
  • Various multivitamins and supplements
• New health product safety information
  • Safety brief
    • Calcium carbonate antacids and milk-alkali syndrome in pregnancy
  • Product monograph updates
    • Clavulin (amoxicillin and clavulanate potassium) and other amoxicillin-containing products
    • Retevmo (selpercatinib)
    • Sodium-glucose cotransporter-2 (SGLT2) inhibitors: Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Forxiga (dapagliflozin), Xigduo (dapagliflozin/metformin), Jardiance (empagliflozin) and Synjardy (empagliflozin/metformin)
• Scope
• Reporting Adverse Reactions
• Helpful links
• Contact us
• References

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in July 2024 by Health Canada.

CPAP and BiLevel PAP machines and mechanical ventilators

Since 2021, Philips Respironics has established a registration portal for affected CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Philips Respironics plans to close its registration portal at the end of December 2024, with the goal of completing its repair and replacement program by the end of June 2025. The company has asked that all customers who have not yet registered their devices do so as soon as possible.

Advisory: CPAP and BiLevel PAP machines and mechanical ventilators

Homemade sunscreens

Health Canada warned the public about the potential risks of making and using homemade sunscreens as they are unlikely to provide effective protection from the sun’s harmful UV rays. Health Canada recommends using only authorized sunscreen products. All sunscreens approved for sale in Canada must have a Drug Identification Number (DIN) or Natural Product Number (NPN).

Advisory: Homemade sunscreens

Mega 2000 and Mega Soft Patient Return Electrodes

Megadyne received reports of patient and healthcare professional burns during or after surgical procedures in which Mega 2000 and Mega Soft Patient Return Electrode pads were used. Corrective actions have been taken to mitigate the potential health risk to healthcare professionals and patients, particularly focusing on children under 12 years of age. Health Canada is working with Megadyne to update the instructions for use for all affected product codes.

Health Professional Risk Communication: Mega 2000 and Mega Soft Patient Return Electrodes

Naloxone Take Home Kits by Canadian Hospital Specialties Ltd.

Naloxone Take Home Kits by Canadian Hospital Specialties Ltd. may contain incorrect naloxone dosing information on the “SAVE ME” instructional card, which could impact the efficacy of the treatment. The product labelling for naloxone indicates that, if necessary, a second dose of the product can be administered 2 to 3 minutes after the first dose. The "SAVE ME" instructional card provided in the kit may recommend re-administration after 3 to 5 minutes. This is an error. A recall was also posted.

Advisory: Naloxone Take Home Kit by Canadian Hospital Specialties Ltd.

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 drug products sold illegally on Quadragen and Advanced Research websites
Advisory: Unauthorized sexual enhancement products

Various multivitamins and supplements

Factors Group of Nutritional Companies Inc. recalled various multivitamins and supplements sold under the following brands: Kirkland Signature, Life, Option+, Webber Naturals, Wellness by London Drugs, Equate, Wellquest, VegiDay, and Natural Factors. The affected products may contain metal fibres which, if ingested, may cause injury to the digestive system.

Advisory: Various multivitamins and supplements

New health product safety information

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

Safety brief

Calcium carbonate antacids and milk-alkali syndrome in pregnancy

Calcium carbonate is a calcium salt that can be found in various antacid formulations. In Canada, calcium carbonate antacids are authorized for the symptomatic management of gastroesophageal reflux disorder (GERD).^{Footnote 1Footnote 2} The symptoms of GERD are common during pregnancy. Hormonal changes can cause the valve at the entrance to the stomach to relax, allowing some acid to pass through and cause symptoms.^{Footnote 3Footnote 4}

Milk-alkali syndrome (MAS) is a rare condition characterized by a triad of hypercalcemia, metabolic alkalosis, and acute kidney injury that typically occurs due to excessive ingestion of calcium in combination with absorbable alkali (such as calcium carbonate antacids). If left untreated, MAS can cause renal failure and systemic calcification.^{Footnote 5} Hormonal changes during pregnancy, which favor increased gastrointestinal calcium absorption, are likely to contribute to an elevated risk of MAS in the setting of high calcium intake.^{Footnote 4}

As of February 14th, 2024, Health Canada has received 2 Canadian adverse reaction reports and has identified 8 literature reports (including 1 Canadian) involving MAS in pregnancy associated with calcium carbonate antacid exposure. In all reports, MAS in pregnant individuals was associated with excessive intake of a calcium carbonate antacid product. When reported, dosing varied substantially between cases. However, in all cases, the dose and/or duration of consumption of calcium carbonate antacids exceeded labelled recommendations. In one case, a patient who developed MAS was reported to have taken upwards of 10 tablets per day (2000 mg elemental calcium per day), while in another case, the patient was consuming approximately 24 tablets per day paired with about 4 pints (approximately 2L) of milk. Commonly reported signs and symptoms of MAS observed in pregnant individuals included hypercalcemia, acute kidney injury, hypertension, nausea and vomiting, and lethargy/altered level of consciousness. Three case reports described reduced/impaired fetal heart rate variability. All reported birth outcomes were considered favorable, with proper medical management of MAS. No fatal cases were identified for either the pregnant individual and/or the fetus or baby. In most cases, there was limited information as well as possible confounding factors (e.g., concomitant medications, medical history, other calcium carbonate sources, etc.) which prevented definitive causal associations from being determined.

Health Canada will also be communicating this issue through various social media channels to raise public awareness and promote proper product use.

Health Canada will continue to monitor the safety of calcium carbonate antacids, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monographs, has been included for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs be accessed through Health Canada's Drug Product Database.

Clavulin (amoxicillin and clavulanate potassium) and other amoxicillin-containing products

The Warnings and Precautions, Adverse Reactions and Patient Medication Information sections of the Canadian product monographs for Clavulin and other amoxicillin-containing products^{Footnote *} have been or will be updated with the risk of drug-induced enterocolitis syndrome.

Retevmo (selpercatinib)

The Warnings and Precautions, Adverse Reactions and Patient Medication Information sections of the Canadian product monograph for Retevmo have been updated with the risk of slipped capital femoral epiphysis/slipped upper femoral epiphysis.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors: Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Forxiga (dapagliflozin), Xigduo (dapagliflozin/metformin), Jardiance (empagliflozin) and Synjardy (empagliflozin/metformin)

The Dosage and Administration and Warnings and Precautions sections of the Canadian product monographs for SGLT2 inhibitors^{Footnote **} have been or will be updated with the risk of prolonged diabetic ketoacidosis (DKA) despite SGLT2 inhibitor discontinuation and standard treatment of DKA, and with recommendations on when to interrupt SGLT2 inhibitor treatment prior to major surgical procedures in patients with type 2 diabetes mellitus (T2DM).

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
• 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

References

Note