Health Canada recommends that children and youth not use cough and cold products that contain opioids

Starting date:
February 18, 2019
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-69080

Issue

OTTAWA - The Government of Canada is committed to better informing Canadians about the risks of health products that contain opioids. Following a safety review of cough and cold products containing opioids, Health Canada is advising that Canadian children and adolescents (under 18 years of age) should not use cough and cold products containing codeine, hydrocodone and normethadone, as a precautionary measure.

Health Canada's safety review found that there is limited evidence to support the effectiveness of these products in children and adolescents (under 18 years of age). In addition, while the review did not find any strong evidence linking cough and cold products that contain opioids with opioid use disorders in children and adolescents, it did find that the early use of opioids may be a factor in problematic substance use later in life. Given the lack of strong data on effectiveness and the potential for longer-term risks, the Department is taking action to advise Canadians about the risks of these products.

Health Canada is also asking manufacturers to update their product safety information to reflect the Department's recommendation that children and adolescents (under 18 years of age) not use these products.

Three prescription opioids are authorized to treat cough symptoms in Canada: codeine, hydrocodone, and normethadone. Codeine is also available without a prescription in low-dose formulations to treat cough and cold.

Information for parents and caregivers:

  • Ask your healthcare professional about alternatives to cough and cold products containing opioids for your children or adolescents (under 18 years of age).
  • Always read the labels on your medications and any safety information provided by your pharmacist or other healthcare professional.

In Canada, the use of prescription cough and cold products containing opioids has been declining among children and adolescents over the past five years. The current use of these products by children and adolescents (under 18 years of age) represents a small proportion (4%) of the total opioid cough and cold prescriptions dispensed in Canada.

Health Canada plans to consult with the Drug Safety and Effectiveness Network to study the links between opioid use disorder and related harms and the use of products that contain opioids in Canada. Health Canada will continue to monitor harms involving all products that contain opioids. The Department has also requested that manufacturers of prescription opioid products submit risk management plans to track and monitor risks in the Canadian population.

Given the availability of other non-prescription products containing low-dose codeine and their potential to lead to problematic use, Health Canada has initiated a review of all non-prescription products for children and adolescents that contain codeine to determine whether similar action is appropriate.

Once Health Canada has made a decision based on the available evidence, it will take action, as required, to inform Canadians and healthcare professionals.

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