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Fentanyl Transdermal Systems - New Changes to the Dose Conversion Guidelines - For the Public

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Teva Canada Limited, Ranbaxy Pharmaceuticals Canada Inc., ratiopharm inc., Sandoz Canada Inc. and Pharmascience Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on Fentanyl
Transdermal Systems (Patches)

March 10, 2010

Subject: New Changes to the Dosage Guidelines for Fentanyl Transdermal Systems (Patches)

The manufacturers of Fentanyl Transdermal Systems, in collaboration with Health Canada, would like to inform Canadians of important new changes made to the Dose Conversion Guidelines in the Product Monograph. These guidelines are used to help determine what dosage of Fentanyl Transdermal Systems is appropriate for each individual patient.

Fentanyl Transdermal Systems are skin patches that contain a high concentration of fentanyl. Fentanyl is a very strong opioid narcotic used to help control chronic (long-lasting) pain.

Fentanyl Transdermal Systems (patches) are only intended for use in patients who require continuous around-the-clock pain relief with strong narcotic pain relievers for an extended period of time and who already are taking narcotic pain relievers at a total daily dose of at least 60 mg/day oral Morphine Equivalents.

Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems if the dosage used is too high. Fentanyl Transdermal Systems should not be used in patients who are not already receiving opioid narcotic drugs.

Patients using a Fentanyl Transdermal System should seek emergency medical help immediately if they:

• have trouble breathing, or have slow or shallow breathing
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally
• have a seizure
• have hallucinations

The letters to health care professionals and the notice to hospitals have been posted on the Health Canada Web site.

Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosing and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems:

DURAGESIC^® (fentanyl transdermal system)
DURAGESIC^® MAT (fentanyl transdermal system)
TEVA-fentanyl
ratio-FENTANYL Transdermal System
RAN-FENTANYL TRANSDERMAL SYSTEM
RAN-FENTANYL MATRIX PATCH
CO Fentanyl
PMS-FENTANYL MTX
Sandoz Fentanyl MTX Patch

Managing product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving Fentanyl Transdermal Systems should be reported to the manufacturers or Health Canada at the following addresses:

Authorized by:

Janssen-Ortho Inc.
Cobalt Pharmaceuticals Inc.
Teva Canada Limited
Ranbaxy Pharmaceuticals Canada Inc.
ratiopharm inc.
Sandoz Canada Inc.
Pharmascience Inc.