Health Product InfoWatch, November 2020

Contents

• Health products mentioned in this issue
• Coronavirus disease (COVID-19)
• Monthly recap
• New information
  • Product monograph update: Zofran and Zofran ODT (Oral Disintegrating Tablets) (ondansetron)
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and biologics

• Benzodiazepines and benzodiazepine-like prescription drugs
• Brilinta (ticagrelor)
• Codeine phosphate syrup
• GUM Paroex
• Non-steroidal anti-inflammatory drugs
• Picato (ingenol mebutate gel)
• Zofran and Zofran ODT (ondansetron)

Natural and Non-prescription Health Products

• Benzocaine
• Daily Shield Hand Sanitizers
• Hand sanitizers that may pose health risks
• Non-steroidal anti-inflammatory drugs

Other

• Counterfeit Zytec Germ Buster Hand Sanitizer
• Unauthorized 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.

Monthly recap of health product safety information

The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in October 2020 by Health Canada.

Benzocaine

Benzocaine has been associated with the risk of methemoglobinemia. Health Canada communicated on this safety issue in 2012, 2011  and 2006. Despite these previous warnings concerning this risk, Health Canada is concerned that children under 2 years of age may still be given benzocaine products, given its history of use as a teething pain reliever. Healthcare professionals are reminded to NOT recommend benzocaine-containing products for children under 2 years of age. Health Canada has also communicated this information to Canadians.

• Health Professional Risk Communication – Benzocaine
• Advisory – Benzocaine

Benzodiazepines and benzodiazepine-like prescription drugs

Health Canada is working with market authorization holders to update the safety labelling for benzodiazepines and benzodiazepine-like prescription drugs to provide patients and healthcare professionals with prominent and consistent messaging about severe and potentially life-threatening risks associated with these drugs. The update requested by Health Canada is related to the risks of problematic use and substance use disorder; severe withdrawal symptoms; harm when taken with opioids, which may cause deep drowsiness, respiratory depression, coma and death; and falls and fractures in specified populations.

• Advisory – Benzodiazepines and benzodiazepine-like prescription drugs

Brilinta (ticagrelor)

This safety review evaluated the risk of central sleep apnea associated with Brilinta use. Health Canada's review concluded that there may be a link. Health Canada has requested that the manufacturer update the Canadian product monograph for Brilinta to add a warning about this potential safety issue.

• Summary Safety Review – Brilinta (ticagrelor)

Certain hand sanitizers that may pose health risks

Health Canada advised Canadians that certain hand sanitizers were recalled because they either contain ingredients that are not permitted by Health Canada or are not properly labelled and are missing important information.

• Advisory – Certain hand sanitizers that may pose health risks

Codeine phosphate syrup 5 mg/mL

Laboratoire Atlas Inc. recalled lot number 35MC of ATLAS - Codeine phosphate syrup, 5 mg/mL, (DIN 00050024) because some bottles contained isopropyl rubbing alcohol 70% instead of codeine syrup. This is the result of a labelling error during the packaging process where isopropyl rubbing alcohol products were mistakenly labelled as Codeine phosphate syrup, 5 mg/mL.

• Advisory – Codeine phosphate syrup
• Drug recall – Codeine phosphate syrup

Counterfeit Zytec Germ Buster Hand Sanitizer

The distributor Northern National Sales Inc. recalled a counterfeit version of Zytec Germ Buster Hand Sanitizer 1L (labelled with NPN 80015625, lot number 3329733126).

• Advisory – Counterfeit Zytec Germ Buster Hand Sanitizer

Daily Shield Hand Sanitizers

Bio Life Sciences Corp. recalled all Daily Shield hand sanitizers from retail locations across Canada. Testing of Daily Shield hand sanitizer confirmed the presence of methanol, which is not authorized for use in hand sanitizers and can cause serious health issues. Frequent use of hand sanitizer containing methanol may cause dermatitis, eye irritation, upper respiratory system irritation and headaches. If ingested, methanol can cause severe, even deadly adverse reactions.

• Advisory – Daily Shield Hand Sanitizers

GUM Paroex

Sunstar Americas, Inc. recalled 5 lots of prescription anti-gingivitis oral rinse, GUM Paroex, after testing revealed the presence of Burkholderia lata. Burkholderia lata is a multi-drug-resistant bacteria that has a high potential to cause serious respiratory and other infections in patients with underlying illnesses, such as cystic fibrosis and chronic granulomatous disease or who are immunocompromised.

• Advisory – GUM Paroex
• Drug recall – Gum Paroex

Non-steroidal anti-inflammatory drugs

Health Canada is investigating the use of non-steroidal anti-inflammatory drugs at 20 weeks or later in pregnancy and the rare, but serious, risk of kidney problems in an unborn baby that can lead to low levels of amniotic fluid and possible complications, in response to a Drug Safety Communication recently released by the U.S. Food and Drug Administration on this issue.

• Advisory – Non-steroidal anti-inflammatory drugs

Picato (ingenol mebutate gel, 0.015% and 0.05%)

Health Canada conducted a safety review of Picato and concluded that there may be a link between its use and an increased risk of non-melanoma skin cancer. Due to the unfavourable benefit-risk profile, the manufacturer withdrew Picato from the Canadian market at Health Canada's request. Health Canada has also communicated this information to Canadians.

• Health Professional Risk Communication – Picato (ingenol mebutate gel)
• Information Update – Picato (ingenol mebutate gel)
• Drug recall – Picato (ingenol mebutate gel)

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 – Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite
• Advisory – Various unauthorized health products

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.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected 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 can be accessed through Health Canada's Drug Product Database.

Zofran and Zofran ODT (Oral Disintegrating Tablets) (ondansetron)

The Warnings and Precautions and Consumer Information sections of the Canadian product monograph for Zofran and Zofran ODT have been updated with new safety information concerning the risks during pregnancy.

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 Register
• Drug Shortages Canada
• Stop Illegal Marketing of Drugs and Devices
• List of drugs for exceptional importation and sale

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca

Health Canada
Marketed Health Products Directorate
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

© 2020 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.