Information update

Information Update - Health Canada strengthens safety information for all opioid drugs

Starting date:
December 8, 2017
Type of communication:
Information Update
Source of recall:
Health Canada
Important Safety Information
General Public
Identification number:


December 8, 2017
For immediate release

OTTAWA - Canada is facing an opioid crisis that is claiming the lives of many Canadians from all walks of life. Patients receiving prescription opioids and treating physicians need a clear understanding of the risks associated with these medications to make informed decisions about how to use them as safely as possible or whether to use them at all.

As part of the Government's action to reduce the harms of opioids, Health Canada held a Scientific Advisory Panel on Opioid Use and Contraindications to consider whether the current contraindications for opioid use are sufficient, or whether labelling updates and other actions may be needed to reduce risks to Canadians. The Panel's recommendations, which also consider the recently published Canadian Guideline for Opioids for Chronic Non-Cancer Pain, can be found online here.

After thoroughly assessing the Panel's recommendations, Health Canada is working with manufacturers to update the Canadian labelling of all prescription opioid products. Labelling updates include:

  • Recommendation for a daily opioid threshold dose for the management of chronic non-cancer, non-palliative pain (which aims to reduce risks of adverse events and overdoses associated with taking higher doses of opioids);

  • Recommendation to limit the quantity of opioids prescribed for acute pain (which aims to reduce the duration of use and associated risks of developing dependence and substance use disorder); and

  • Clarification of warnings, including those for special populations such as pregnant women and patients with a history of dependence or substance use disorder.

Health Canada wants to ensure that opioid medications are available to all patients who need them, while limiting the potential for unwanted harms. While prescription opioid labels are being updated to include enhanced information about product risks, they continue to allow for physician discretion to adequately treat individual patients. For example, a recommendation may be presented in the dosing and administration section of the labelling, rather than as a contraindication, so that physicians can continue to consider the relative risks and benefits for individual patients in making their treatment decisions.

To effectively update all of these product labels, Health Canada has prioritized them based on risk. The labelling updates for all prescription opioids are expected to be completed in January 2019. In total, 508 prescription opioids are affected, representing approximately 211 submissions (i.e. a submission can include multiple dosages and each dosage would have its own DIN).

This labelling initiative is part of the latest actions in the Government of Canada's ongoing comprehensive strategy to increase awareness and reduce the harms of opioids for Canadians and their families. Canadians will continue to be updated as the opioid class labelling progresses.

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