Safety Information

Published: 13 October 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Reduced adhesion and efficacy noted by some patients using Mylan Fentanyl Transdermal patches

13 October 2014

Following the funding switch to Mylan Fentanyl patches, a number of complaints were received by Medsafe.  These were investigated and Mylan New Zealand Limited supplied information on patch adherence and included more explicit information in the datasheet and the consumer medicine information.

Reports are still being received relating to Mylan Fentanyl patches where the patch is not sticking properly and detaching after a day or two.  

Some patients also report experiencing withdrawal symptoms after 48 hours that include feelings of extreme chill, nausea and anxiety; that are resolved after replacing the patch with a new patch.

Products Affected

Product name Sponsor
Mylan Fentanyl Transdermal patch Mylan New Zealand

Additional Information

The manufacturer has advised that there are many usage factors that can affect adhesive properties of these patches.  It is noted that transdermal patches do not adhere equally well to all patients due to differences in skin characteristics.  Application of the Mylan patch strictly in accordance with the recommended procedure will ensure the best outcomes.

Please find a link to the New Zealand Consumer Medicine Information below, this outlines the procedure for applying the Mylan Fentanyl patches.

http://www.medsafe.govt.nz/consumers/cmi/m/mylanfentanyl.pdf

It is also noted in the data sheet that as the management of chronic pain is complex, doses should be individualised based on the status of the patient and pain management should be assessed at regular intervals throughout the treatment.  Some patients may require the patch to be applied every 48 hours rather than 72 hours. 

Please find a link to the New Zealand Data sheet below.

http://www.medsafe.govt.nz/profs/datasheet/m/mylanfentanylpatch.pdf

Regulator Actions

Medsafe is continuing to monitor reports relating to Mylan fentanyl patches.

Reporting

Consumers and healthcare professionals are encouraged to report problems with medicines to Medsafe. Please contact us at recalls@moh.govt.nz.

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

How to report an adverse reaction