Health Canada is taking new action to improve the safe use of two prescription opioid drugs, codeine and hydrocodone, to help further address the rare but potentially life-threatening risk of breathing problems in children and adolescents. Serious breathing problems known as respiratory depression (slowed breathing) are a known risk with the use of any opioid, particularly when too much is taken.
The action is in light of Health Canada safety reviews that identified the need for new warnings and restrictions on prescription codeine and hydrocodone products, to enhance their safe use. Prescribers are advised to take note of the following determined in the review:
• codeine should no longer be used (contraindicated) in patients under 18 years of age to treat pain after surgery to remove tonsils or adenoids, as these patients are more susceptible to the risk of serious breathing problems. Codeine (prescription and non-prescription) is already not recommended for children under the age of 12, for any use.
• hydrocodone is no longer recommended in patients under six years of age. This recommendation is based on rare cases of serious breathing problems including deaths in children in this age group, usually involving higher-than-recommended doses.
Currently in Canada, codeine-containing products are used to relieve pain or to treat cough while hydrocodone is used to treat cough. Health Canada reviewed codeine as a follow up to its decision in 2013 to restrict its use in children under 12 years old to see what, if any, new actions might be needed to further address the risk of serious breathing problems in patients under 18 years of age. The review determined a need to look at hydrocodone because cases of respiratory depression in children were also identified for hydrocodone. Health Canada is working with manufacturers to incorporate the new restrictions into the prescribing information (product monographs) for these drugs.
Patients of all ages should stop taking their opioid medication and seek medical attention immediately if they observe breathing problems, such as slow, shallow or weak breathing, sudden shortness of breath or difficulty breathing, dizziness, confusion, or extreme sleepiness. To reduce the risk of breathing problems, opioids should be taken only as prescribed. In particular, codeine and hydrocodone should not be used by patients who have breathing problems.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../59584a-eng.php
In Hong Kong, there are 320 registered pharmaceutical products containing codeine, and no registered product containing hydrocodone. News regarding the use of codeine in children was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2012, with the last update posted on 5 July 2016. Letters to inform local healthcare professionals of the risk of respiratory depression were issued on 16 August 2012, and further letters on codeine restricted for use in children aged 12 and above were issued on 7 June 2013. So far, the Department of Health (DH) has not received any adverse drug reaction report related to codeine.
On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack label and/or package insert of pharmaceutical products containing codeine should be updated to include the relevant safety information which is similar to the recommendation in the above Health Canada announcement. As previously reported on 2 July 2015, the US FDA has started evaluating the potential risk of serious side effects of codeine. DH will remain vigilant on the review's result and safety updates of codeine by other overseas drug regulatory authorities for consideration of any further action deemed necessary.
Ends/ Friday, July 29, 2016
Issued at HKT 15:00
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