其 他 安 全 警 示
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| Canada: Summary Safety Review - Opioid-containing cough and cold products - Assessing the potential risk of opioid use disorder and related harms in children and adolescents (English Only) |
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Health Canada announces that it reviewed the risk of opioid use disorder and related harms from cough and cold products containing opioids (including codeine, hydrocodone or normethadone) after the US Food and Drug Administration (FDA) advised against using these products in children and adolescents in 2018.
At the time of this review, Health Canada found limited information on reports of opioid use disorder among children and adolescents related to the use of opioid-containing cough medications from either Canadian or international reports. Like other opioids, codeine, hydrocodone, and normethadone may lead to opioid use disorder. However, it is often difficult to detect and recognize the signs and symptoms of opioid use disorder in children and adolescents, and these may go unreported. A review done by the Canadian Agency for Drugs and Technologies in Health found a lack of published evidence to support codeine use in children for cough and cold symptoms. Health Canada reviewed the published literature, which 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. The scientific literature also suggests a possible link between exposure to opioid-containing products in adolescence and a higher risk of problematic opioid use later in life. National and provincial data indicate a concerning increase in opioid-related harms in children and adolescents.
Health Canada's safety review found limited evidence to link opioid-containing cough and cold products with opioid use disorders and related harms in children and adolescents. These products are linked to other known harms (i.e., breathing problems), and there is limited evidence to support the effectiveness of these products in children and adolescents. There are other products available in Canada to help relieve the symptoms of cough and cold in children.
Therefore, Health Canada, as a precautionary measure, is advising Canadians against the use of these products among children and adolescents under 18 years of age. Health Canada will notify the manufacturers to update the product safety information of opioid-containing cough and cold products to limit the recommended age of use (indication) to adults only, 18 years of age and older. Health Canada will also inform Canadians and healthcare professionals about these updates through an Information Update and a Health Product InfoWatch communication.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00216
In Hong Kong, there are 333 registered pharmaceutical products containing codeine, which is an ingredient used to relieve cough. There is no registered pharmaceutical product containing hydrocodone or normethadone. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to codeine. News related to the limitation of the use of opioid-containing cough and cold medicines to adults (18 years of age and older) was previously issued by the FDA and China National Medical Products Administration (NMPA), and was posted on the Drug Office website on 12 Jan 2018 and 7 Sep 2018. Letters to inform local healthcare professionals were issued on 12 Jan 2018.
On 12 Jun 2018, the Registration Committee of the Pharmacy and Poisons Board (Registration Committee) discussed the matter, and decided to keep vigilant on any update from other health authorities. The DH will remain vigilant on safety update of the matter issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Tuesday, Feb 19, 2019
Issued at HKT 17:00
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