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Label changes for controlled-release opioid pain medicines encourage more targeted prescribing and safer use
- Starting date:
- August 18, 2014
- Posting date:
- August 18, 2014
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Identification number:
OTTAWA - Health Canada is advising healthcare professionals and Canadians that it has implemented labelling changes for the class of drugs known as controlled-release opioid pain medicines, to enhance their safe and appropriate use.
The changes provide standardized wording that more clearly outlines the risks and safety concerns associated with controlled-release opioids. The updated label also encourages more appropriate patient selection and monitoring.
While an effective pain treatment, opioid medications carry risks and can have serious negative health impacts, even at recommended doses. Their use can also lead to accidental overdose and death. The label changes seek to reduce these risks, which include addiction, misuse and abuse, while preserving access for those who need them most.
There are currently 38 brand name and generic controlled-release opioid medicines in Canada and include, among others, controlled-release versions of morphine, oxycodone, and fentanyl.“Controlled release” medications are designed to be long acting, meaning they produce gradual, steady absorption of the drug in the body over an extended period of time, which allows patients to take them less often.
The changes apply now to all classes of controlled and extended release non-generic opioids. Similar label changes will soon be implemented for generic opioids.
The approved use for all opioids in this class has been modified to remove use for “moderate” pain. The new label clarifies that these drugs are indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment that is opioid-responsive and for which alternative treatment options are not adequate. The changes preserve the ability for prescribers to choose appropriate treatment for their patients, but provide clearer guidance on the recommended patient population.
In addition, existing warnings and safety information have been made clearer, including health risks to children from accidental exposure and to newborns exposed during pregnancy. Warnings with respect to opioid addiction potential have also been strengthened and made clearer. As well, the changes standardize label information, and ensure information targeted to patients is easier to read and understand.