Health Canada Recalls Fentanyl Transdermal Pain Patches

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Main Category: Pain / Anesthetics
Also Included In: Public Health
Article Date: 17 Feb 2008 - 11:00 PDT

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Canadians are being advised not to use 25 mcg/hr Duragesic (fentanyl transdermal system) patches (Janssen-Ortho Inc.) and 25 mcg/hr Ran Fentanyl Transdermal System patches (Ranbaxy). The manufacturers are voluntarily recalling Duragesic and Ran Fentanyl Transdermal System 25 mcg/hr patches as it is possible they may have a cut along one side, raising the risk of the fentanyl gel leaking from the patch.

Duragesic and Ran Fentanyl Transdermal System patches are prescription pain medications, commonly used for patients with constant moderate/severe chronic pain. If the fentanyl gel leaks from the patch the patient may absorb too much of it through the skin, resulting in serious, and sometimes life-threatening adverse-events, including slowed breathing and potential overdose. Fentanyl overdose is life-threatening.

Health Canada is asking patients and their carers to return the drugs to their local pharmacy. Do not handle the patches directly. If you have been using 25 mcg/hr strength of Duragesic or Ranbaxy Fentanyl patch you should contact your doctor for advice on a suitable alternative medication.

If your skin does become exposed to leaking fentanyl gel you should thoroughly rinse the exposed skin with plenty of water - do not use alcohol or soap. If you have used this medication and are concerned you should contact your doctor, Health Canada advises.

Signs of fentanyl overdose:

-- confusion
-- difficult or shallow breathing
-- dizziness
-- extreme sleepiness/sedation
-- feeling faint
-- inability to think, talk or walk normally
-- tiredness

If you or someone you care for shows signs of fentanyl overdose you should seek medical help immediately.

It is also possible that a defective patch with leaking gel may not provide effective pain relief.

To report a suspected adverse reaction to this product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.

Health Canada

Written by - Christian Nordqvist
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