Health Canada is informing Canadians and healthcare professionals about changes to the product labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines.The Department is updating the label of the Janssen COVID-19 Vaccine to provide additional information about the very rare risk of immune thrombocytopenia (ITP), an autoimmune condition, and the rare risk of venous thromboembolism...
Ivermectin not authorized to prevent or treat COVID-19; It may cause serious health problems
Health Canada has received concerning reports of the use of veterinary ivermectin to prevent or treat COVID-19. Canadians should never consume health products intended for animals because of the potential serious health dangers posed by them. In this light, Health Canada is advising Canadians not to use either the veterinary or human drug versions of...
Real World Evidence for COVID-19 Vaccines
Similar to clinical trials, real world cohort and case-control studies find COVID-19 infections are reduced by >90% with two doses of mRNA vaccines. Single doses of either mRNA or AstraZeneca vaccine decreases infections by ~60% and hospitalizations by 70-80%. Vaccine effectiveness appears similar for variants of concern and are safe for pregnant women. HMC
Updated information on AstraZeneca/COVISHIELD COVID-19 vaccines
On June 29, 2021, Health Canada issued a Health Product Risk Communication regarding the AstraZeneca/COVISHIELD COVID-19 vaccine: https://healthycanadians.gc.ca/recall-alert-rappel- avis/hc-sc/2021/75389a-eng.php Health Canada has updated the product monograph for the AstraZeneca and COVISHIELD COVID-19 vaccines to add capillary leak syndrome as a potential side effect following vaccination. Patients with a history of capillary leak syndrome should not...
Dear community members and families, In the last few weeks, we have seen significant movement in our understanding of the COVID-19 vaccines. As of today, here is what we know: The vaccines are safe The vaccines approved for use in Canada work by sending a message to our body’s immune system to stimulate our natural immune response....
Important Safety Information on the Authorization of Moderna COVID-19 Vaccine with English-only Vial and Carton Labels – Moderna Biopharma Canada Corporation
Moderna COVID-19 Vaccine was authorized for use in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. As an extraordinary measure to provide earlier access to vaccine supplies in the context of the global pandemic, Moderna is providing, at this time, vaccine vials and cartons...
Health Canada warns Canadians not to buy COVID-19 vaccines sold online or from unauthorized sources
Health Canada is warning Canadians not to buy COVID-19 vaccines sold on the internet or from unauthorized sources as they are counterfeit. Counterfeit COVID-19 vaccines may pose serious health risks, and are ineffective at protecting an individual from the COVID-19 virus. HMC
More Info about COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies
Two individuals in the U.K. reported severe allergic reactions to Pfizer BioNTech’s COVID-19 vaccine on December 8, 2020. As vaccine roll-out begins in Canada, Canadians may be wondering about the risks of allergic reactions and if they should receive this vaccine if they have allergies to foods or other medications. Health Canada has reviewed the...
Ultraviolet (UV) lights and wands falsely claiming to disinfect against COVID-19
Health Canada is warning Canadians about the risks of using ultraviolet (UV) lights and wands that make unproven claims to disinfect against the COVID-19 virus. HMC
Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) beyond 20 weeks of pregnancy and risk of kidney damage in unborn babies, leading to low amniotic fluid
Health Canada is investigating the use of NSAIDs 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. FDA on this...
Updates to safety labelling for benzodiazepines and benzodiazepine-like drugs
Benzodiazepines and benzodiazepine-like prescription drugs—commonly used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle pain—can lead to problematic use and substance use disorder. To help mitigate these risks, Health Canada is asking manufacturers to update their safety warnings to include more prominent and consistent messaging for...
PICATO (ingenol mebutate gel, 0.015% and 0.05%) – Product Withdrawal in Canada due to Potential Increased Risk of Skin Cancer
At Health Canada’s request, LEO Pharma Inc. is withdrawing Picato from the Canadian market. This follows a safety review by the Department, which concluded that use of Picato may be associated with an increased risk of non-melanoma skin cancer, and that the benefits of using Picato no longer outweigh its potential risks. HMC
Benzocaine products should not be used in children under two years of age
Health Canada is reminding parents and caregivers not to use products containing benzocaine in children under two years of age. Benzocaine products may cause a serious blood condition called methemoglobinemia (MetHb), which reduces the ability of red blood cells to deliver oxygen throughout the body. Over-the-counter (OTC) products that contain benzocaine are used in children...
All strengths of MAR-Diltiazem CD, a drug used to treat angina and hypertension, have been recalled because of dosing concerns
Health Canada is informing Canadians that Marcan Pharmaceuticals has recalled all lots of all MAR-Diltiazem CD products in response to data integrity concerns that could lead to incorrect dosing. HMC
Recall of certain hand sanitizers that contain technical-grade ethanol
Health Canada is advising Canadians that certain lots of the following hand sanitizer are being recalled from the market because they contain ethanol or denaturants that are not acceptable for use in hand sanitizers in Canada. Product Unacceptable Ingredient Recalling Company NPN or DIN Lot numbers Expiry Date Date Added Clean & Green Hand Sanitizer...
Non-prescription pain relief products containing codeine are not recommended for use in people under 18 years of age
Health Canada is advising Canadians that people under 18 years of age should not use non-prescription pain relief products containing codeine. HMC
Unauthorized test kits claiming to diagnose or detect COVID-19 put your health at risk
Health Canada is warning Canadians not to buy home diagnostic test kits, including mail-in sample collection kits, claiming to diagnose or detect COVID-19 because they may provide inaccurate or false results. These products have not been authorized by Health Canada, which means they have not been reviewed for safety, quality or effectiveness. HMC
Chloroquine and hydroxychloroquine can have serious side effects. These drugs should be used only under the supervision of a physician.
Health Canada is concerned that some people may be directly buying and using chloroquine and hydroxychloroquine to prevent or treat COVID-19 without a prescription. Chloroquine and hydroxychloroquine may cause serious side effects, including serious heart rhythm problems. The risk of these side effects may increase at higher doses, or if the drugs are used in...
Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19
Health Canada has received reports that fraudulent and uncertified N95 respirators that falsely claim to protect consumers against COVID-19 are being illegally sold to consumers online and in some stores. In Canada, N95 respirators are regulated by Health Canada as Class I medical devices and are manufactured or imported by companies that hold a Medical Device Establishment...