Other safety alerts
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| Canada: Methadone treatment of opioid dependence and potential differences in product effect |
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Health Canada announces that it has received reports from patients and healthcare professionals that there may be variations in how patients respond to different formulations of methadone when used for opioid substitution treatment in opioid drug dependence. As a precautionary measure, Health Canada would like to relay this information to healthcare professionals so that they are aware of the issue and monitor their patients accordingly. The affected products are:
- Metadol-D (methadone hydrochloride oral solution 1mg/ml, DIN 02247374) by Paladin Labs Inc.
- Metadol-D (methadone hydrochloride oral concentrate 10mg/ml, DIN 02244290) by Paladin Labs Inc.
- Methadose (methadone hydrochloride oral concentrate 10mg/ml, DIN 02394618) by Mallinckrodt Canada ULC
- Methadose (methadone hydrochloride oral concentrate 10mg/ml, DIN 02394596) by Mallinckrodt Canada ULC
- Sandoz Methadone (methadone hydrochloride oral concentrate 10mg/ml, DIN 02481979) by Sandoz Canada Inc.
Following recent concerns about differences in how patients were responding to various methadone formulations when switching products, Health Canada has been engaging stakeholders to seek additional information to characterize the extent of the issue. It has been observed that some patients display signs of opioid withdrawal and report symptoms when they are switched from their pre-existing methadone formulation to a new one. Some of these patients had been stable for years and upon starting the new formulation, presented signs of withdrawal prior to their next dose of methadone. The reasons for the reported and observed variability in clinical response to different methadone formulations is still unclear. Patients experiencing early onset of withdrawal symptoms may reinitiate or increase problematic substance use and quit their treatment program, which can have a significant impact on their wellbeing and of that of their families. As part of the Government of Canada’s response to the opioid crisis, Health Canada developed this risk communication to draw awareness to this potential issue.
Patients taking Metadol-D, Methadose or Sandoz Methadone who develop symptoms of opioid withdrawal should seek medical help. Symptoms may include rapid heart rate, feeling nervous or restless, swelling, nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, and sweating. Patients should contact their healthcare professional if they have concerns about how well their medication is working as adjustments to their dose may be required.
Healthcare professionals are being advised that:
- Some patients may experience withdrawal symptoms after being switched from one formulation to another; these patients should be clinically managed and monitored regularly.
- If patients are stable on their methadone treatment and can be maintained on that product, it is advisable to avoid switching products, when possible.
- Early withdrawal symptoms can lead to a failure to remain in treatment and subsequent problematic substance use, which can lead to serious harms.
Health Canada is working with stakeholders to examine the issue and will update Canadians when new, relevant information is available, following completion of the Department’s ongoing review.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../72675a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products.
There is one registered pharmaceutical product containing methadone which is indicated for opioid dependence and currently available in the Hong Kong market, namely, Methadone Linctus 80mg/20ml (New Formula) (HK-65009), and is a prescription-only medicine. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to methadone, but these cases are not related to switching of methadone products. As there is only one methadone product for opioid dependence currently available in Hong Kong, the above Health Canada’s announcement of potential differences in product effect does not have any impact on Hong Kong.
Ends/Wednesday, Apr 1, 2020
Issued at HKT 16:00
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