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Public Advisory Health Canada Endorsed Important Safety Information DURAGESIC* (fentanyl transdermal system)

Sep 16, 2005 | CNW

Janssen-Ortho Inc., in collaboration with Health Canada, wishes to highlight important safety information about the safe use of DURAGESIC.

The Canadian Product Monograph for DURAGESIC has been revised to emphasize this safety information, and contains a section with Consumer Information to ensure that patients and their caregivers are aware of the guidelines for the safe use of DURAGESIC.

DURAGESIC contains a high concentration of a potent and long-acting narcotic agent called fentanyl, which is administered through the skin by a patch system to relieve pain.

Fentanyl, similar to other strong opioid pain medications, has demonstrated a risk of fatal overdose. The most serious effect of fentanyl overdose is hypoventilation (slowed breathing). Serious or life-threatening cases of hypoventilation (including deaths) have been reported in association with the use of DURAGESIC.

Other symptoms of fentanyl overdose include difficult or shallow breathing, tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.

Patients and their caregivers should be aware of the signs and symptoms of fentanyl overdose, and should seek medical attention immediately if any of these symptoms are noted.

DURAGESIC is used in adults for the management of persistent, moderate to severe chronic pain that cannot be managed by lesser means. It should not be used for short-term, intermittent or post-operative pain, or in patients who are not already using some form of strong opioid pain medication.

The use of DURAGESIC in children under 18 years of age is not recommended, as dosage requirements for the safe and effective use of DURAGESIC have not been established for children. There have been reports of deaths in children using DURAGESIC in Canada.

The potential for serious adverse events may be increased in patients who use DURAGESIC along with some other prescription medications that affect how fentanyl is broken down in the body.

Patients should tell their doctors if they are taking any other prescription medications; use DURAGESIC in combination with alcohol and any other medications: such as sleeping pills, muscle relaxants, antihistamines or any other over-the-counter medications that affect brain functions; have fever; are exposed to direct external heat sources.

All patients who use DURAGESIC should be advised to avoid external heat sources such as heating pads, electric blankets, heated water beds, heat lamps, hot water bottles, saunas and hot whirlpool spa baths, intensive sunbathing, etc. do not follow exactly the directions for safe use or the approved labeling.

The potential exists for misuse and abuse of DURAGESIC patches. There have been reports of deaths in Canada involving misuse and abuse. Consumers should be aware of the importance of safe storage and proper disposal instructions for DURAGESIC.

Patients, family members and caregivers should protect DURAGESIC from theft or misuse in the work or home environment.

The Canadian Product Monograph currently recommends to fold the patch such that the adhesive side sticks to itself and to flush it down the toilet immediately after removing it from the skin. Any unused patches should be disposed of in the same manner.

Janssen-Ortho Inc. has provided this information to physicians and pharmacists across Canada. This advisory and letters issued to physicians and pharmacists can be accessed at Health Canada's website.

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