Methadone Treatment of Opioid Dependence and Potential Differences in Product Effect

Starting date:
March 31, 2020
Posting date:
March 31, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-72675

Last updated:

 

Audiences

Healthcare professionals including general practitioners, family physicians, nurse practitioners, pharmacists and addiction specialists

Key messages

  • Health Canada is aware of concerns of variable responses by patients after their methadone formulation is switched to a different formulation during the treatment of opioid dependence.
  • Some patients including those who have been stable for years, have reported symptoms of opioid withdrawal after being switched from one methadone formulation to another.
  • Healthcare professionals should be aware 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 may 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.
  • 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.

             

Issue

Health Canada 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.

Products affected

Brand/
Product Name
Medicinal Ingredient and Strength DIN Manufacturer
Metadol-D methadone hydrochloride oral solution, 1 mg/mL 02247374 Paladin Labs Inc.
Metadol-D methadone hydrochloride oral concentrate, 10 mg/mL 02244290 Paladin Labs Inc.
Methadose methadone hydrochloride oral concentrate, 10 mg/mL 02394618 Mallinckrodt Canada ULC
Methadose methadone hydrochloride oral concentrate, 10 mg/mL 02394596 Mallinckrodt Canada ULC
Sandoz Methadone methadone hydrochloride oral concentrate, 10 mg/mL 02481979 Sandoz Canada Inc.

 

Background information

Currently in Canada, Metadol-D, Methadose, and Sandoz Methadone are used for substitution treatment for opioid dependence in adults.

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.


 

Who is affected

 

Information for consumers

Methadone is prescribed for use in patients requiring substitution treatment for opioid drug dependence. It can also be used as part of a treatment plan that includes social and psychological support. It is important that patients comply with their dosing schedule in order to maximize their treatment success. 

Some patients, after being switched from one methadone formulation to another, may experience symptoms of opioid withdrawal. 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.

Information for healthcare professionals

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.

Action taken by Health Canada

Health Canada is working to better understand the issue and will update Canadians when new, relevant information is available, as Health Canada completes its ongoing review.

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.


 

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any changes in patient response, including withdrawal symptoms, or other serious or unexpected adverse reactions in patients receiving methadone should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

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

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738