Information Update - New safety measures for prescription codeine and hydrocodone to further restrict use in children and adolescents

OTTAWA, July 28, 2016 /CNW/ - 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. Specifically, the reviews determined that:

• 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.

Health Canada is working with manufacturers to incorporate the new restrictions into the prescribing information (product monographs) for these drugs.

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 will continue to monitor these drugs as it does all drugs available in Canada to ensure that their health benefits continue to outweigh their risks when used as prescribed.

What should you do:

• Prescribers, caregivers and patients are advised that prescription codeine should not be given to patients under the age of 18 if they are having (or have recently had) surgery to remove tonsils or adenoids, and hydrocodone is no longer recommended in children under the age of six.
• Health Canada reminds that codeine products (prescription and non-prescription) are not recommended for children less than 12 years old.
• 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.
• Canadians with questions or concerns about their opioid treatment or about alternatives should speak to their healthcare professional.

Additional information for healthcare professionals:

• Healthcare professionals are reminded that all opioids should be prescribed in the lowest effective dose to reduce the chance of side effects. Practitioners are encouraged to be judicious in their prescribing, per practice guidelines, and to consider the potential for adverse events with these drugs when making treatment decisions.
• Detailed safety and prescribing information is provided in the Canadian Product Monographs for these drugs, which are available in the Drug Product Database.

Report health or safety concerns
To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related links:

• Summary Safety Review: Codeine-containing products - Further assessing the risk of serious breathing problems in children and adolescents (July 2016)
• Summary Safety Review: Hydrocodone-containing products - Further assessing the risk of serious breathing problems in children and adolescents (July 2016)
• Codeine no longer recommended for children under 12 (June 2013)
• Codeine and nursing mothers – Information for healthcare professionals and the public (October 2008)
• Using opioids safely
• Drug Product Database

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SOURCE Health Canada

For further information: Media Inquiries: Health Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709