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

Starting date:

March 10, 2010

Posting date:

March 10, 2010

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000866

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.

Notice about Health Canada advisories

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.

• Health Care Professionals and hospitals have been informed of the new changes made to the Dose Conversion Guidelines. These new Guidelines will allow them to adjust doses appropriately.

• The dosage of Fentanyl Transdermal Systems must be calculated using the new conversion table, and must not be higher than the dose recommended.

• Patients using Fentanyl Transdermal Systems should not stop or change their dosage without first consulting with their doctor. This medicine should always be used exactly as prescribed.

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:

Janssen-Ortho Inc.

Drug Safety Department

19 Green Belt Drive

Toronto, Ontario M3C 1L9

Telephone: 1-800-567-3331

Fax: 1-866-767-5865

dsscan@joica.jnj.com

Cobalt Pharmaceuticals Inc.

6500 Kitimat Road

Mississauga, Ontario L5N 2B8

Telephone: 1-866-254-6111

Fax: 905-542-0478

Teva Canada Limited

Pharmacovigilance and Drug Safety

30 Novopharm Court

Toronto, Ontario M1B 2K9

Telephone: 416-291-8888 ext. 5005

Fax: 416-335-4472

E-mail: PhV@tevacanada.com

Ranbaxy Pharmaceuticals Canada Inc.

2680 Matheson Blvd. East, Suite 200

Mississauga, Ontario L4W 0A5

Telephone: 1-866-840-1340

Fax: 905-602-4216

ratiopharm inc.

17800 Lapointe

Mirabel, Quebec J7J 1P3

Telephone: 1-800-337-2584

Fax: 1-800-313-7673

www.ratiopharm.ca

E-mail: drugsafety@ratiopharm.ca

Sandoz Canada Inc.

Pharmacovigilance General Contact

145 rue Jules-Léger

Boucherville, Québec J4B 7K8

Telephone: 1-800-343-8839 ext 4636

Fax: 450-641-6408

Email: drugsafety.canada@sandoz.com

Pharmascience Inc.

Medical Information Dept.

6111 Royalmount Ave., Suite #100

Montreal, Quebec H4P 2T4

Telephone: 514-344-0764 or 1-888-550-6060

Fax: 1-514-340-0164

E-mail: adr@pharmascience.com

Any suspected adverse reaction can also be reported to:

Canada Vigilance Program

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701D

Ottawa, Ontario, K1A 0K9

Telephone: 613-957-0337 or Fax: 613-957-0335

CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:

Telephone: 1-866-234-2345

Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

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

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Authorized by:

Janssen-Ortho Inc.

Cobalt Pharmaceuticals Inc.

Teva Canada Limited

Ranbaxy Pharmaceuticals Canada Inc.

ratiopharm inc.

Sandoz Canada Inc.

Pharmascience Inc.