Health Canada to Need Precautionary Statements in Antimicrobial Labels

As part of initiatives to motivate the more prudent prescribing and use of antimicrobials, Health Canada on 16th November 2015 announced it will now need the addition of precautionary statements in antimicrobial product

The proposal, which was declared together with the kickoff of World Antibiotic Awareness Week, occurs as bacteria are progressively stronger, more resistant to antibiotics and consequently more lethal. As part of its national action strategy on antimicrobial resistance, Health Canada states that it will need drug sponsors’ monographs to be modified as follows:

Part I: Indications and Clinical Use

“To decrease the progression of drug-resistant bacteria and manage the effectiveness of Product X and other antibacterial medicines, Product X must be used only to deal with infections that are confirmed or strongly assumed to be triggered by susceptible bacteria. When culture and susceptibility details are accessible, they must be regarded in selecting or changing antibacterial therapy. In the absence of like data, local epidemiology and susceptibility patterns may play a role to the empiric selection of therapy.”

Part II: Warnings and Precautions

“Prescribing Product X in the absence of a confirmed or strongly assumed bacterial infection is not likely to offer advantage to the individual and risks the progression of drug-resistant bacteria.”

Part III: Patient Medication Information

“Antibacterial medicines like Product X deal with only bacterial infections. They do not deal with viral infections like as the common cold. Even though you may feel better early in therapy, Product X must be taken accurately as directed. Neglect or overuse of Product X could result in the development of bacteria that will not be wiped out by Product X (resistance). This indicates that Product X may not work for you in the long term. Do not share your medicine.”


As far as industry execution of these modifications, Health Canada mentioned that present antimicrobials will be updated “in a phased approach in reaction to a particular request by Health Canada to the appropriate sponsor.”

Health Canada also will be delivering an advisement letter to sponsors in a phased approach over the coming months to demand a labelling update. “Sponsors must wait till they get the request from Health Canada so as to facilitate workload management,” the regulator says.

In add-on, sponsors of products that do not have a “Prescribing Information” record and/or a Part III: Patient Medication Data component, must create one and file it with their submission. And if a submission is being submitted for other factors than the inclusion of the precautionary statements, sponsors may upgrade their product monograph(s), the regulator says.

Health Canada Notice