其 他 安 全 警 示
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| Canada: Prescription cough and cold products containing opioids and the risk of opioid use disorder in children and adolescents (English only) |
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Health Canada announces that it published a summary of a safety review of opioid-containing products indicated for cough and cold in 2019, which found limited evidence to support the effectiveness of these products in children and adolescents (under 18 years of age). The review also found limited evidence to link these products with opioid use disorders and related harms in children and adolescents. As a precautionary measure, Health Canada has now limited the use of opioid-containing products indicated for cough and cold for adults only (patients 18 years of age and older) and has notified manufacturers of these products to update the indication and other relevant sections of the Canadian Product Monographs (CPMs) to include this new safety information.
Currently in Canada, codeine-containing products have been authorized to relieve pain or supress cough, while products containing hydrocodone and normethadone have been authorized for cough suppression only.
Following a safety review of cough and cold products containing opioids (codeine, hydrocodone and normethadone), Health Canada issued a risk communication on 18 Feb 2019 recommending children and adolescents not to use cough and cold products that contain opioids. The prescription codeine-containing products indicated for pain relief were not in scope of this specific safety review completed by Health Canada at that time.
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. The review also found limited evidence to support the effectiveness of these products in children and adolescents. Literature suggests that adolescents are at a greater risk of problematic opioid use and overdose, while younger children are at a greater risk of accidental poisoning.
As part of the Government of Canada’s ongoing comprehensive strategy to increase awareness and reduce the harms of opioids for Canadians, Health Canada has required the labelling of prescription cough and cold containing opioids to be updated, and continues to work with manufacturers to include enhanced information about the product’s risks and limit the use of these products for adults only. Labelling for non-prescription products containing low-dose codeine to treat cough and cold has also been required to be updated with this safety information.
Healthcare professionals are being advised that:
- Prescription cough and cold products containing opioids are no longer indicated in patients younger than 18 years of age since there is a risk of opioid toxicity due to the variable and unpredictable metabolism of codeine or hydrocodone; and the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of opioids in these patients.
- Parents should be advised that cough due to cold or upper respiratory infections is self-limited and generally does not need to be treated.
- For those children and adolescents requiring cough treatment, non-opioid alternatives are available.
- Should the non-opioid alternatives fail, always advise patients and parents/caregivers of the risks associated with opioid medications and use the lowest effective dose for the shortest duration of time possible.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../73741a-eng.php
In Hong Kong, there are 357 registered pharmaceutical products containing codeine. There is no registered pharmaceutical product containing hydrocodone or normethadone.
News related to the limitation of the use of opioid-containing medicines to adults (18 years of age and older) was previously issued by the United States Food and Drug Administration, China National Medical Products Administration and Health Canada, and was posted on the Drug Office website on 12 Jan 2018, 7 Sep 2018, 19 Feb 2019 and 1 Aug 2020. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 12 Jan 2018. In Jun 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided to remain vigilant on safety update issued by other overseas drug regulatory authorities.
So far, the DH has received 4 cases of adverse drug reaction related to codeine.
The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Tuesday, Aug 25, 2020
Issued at HKT 15:00
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