Darvon-N (dextropropoxyphene) - Recall and Withdrawal in Canada - For the Public

Starting date:

December 1, 2010

Posting date:

December 1, 2010

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-16115

This is duplicated text of a letter from Paladin Labs 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 Darvon-N: Recall and Withdrawal in Canada

December 1, 2010

Subject:Recall and Withdrawal of ^NDarvon-N^® (dextropropoxyphene) in Canada

In collaboration with Health Canada, Paladin Labs Inc. has decided to voluntarily recall and withdraw all lots of ^NDarvon-N^® (dextropropoxyphene, also known as propoxyphene) on the Canadian market and discontinue the sale of the product. This decision follows a United States Food and Drug Administration (FDA) request that all manufacturers of propoxyphene, an opioid pain reliever used to treat mild to moderate pain, withdraw their products from the U.S. market The withdrawal is based on all available data, including data from a new study that evaluated the effects of increasing doses of dextropropoxyphene on the heart.

• Results of a new study show that, even at doses normally taken to manage pain, dextropropoxyphene can significantly increase the risk of serious abnormal heart rhythms. This can be important in elderly patients and those with kidney problems as they may be more likely to experience the heart rhythm effects of dextropropoxyphene.
• Patients are asked to talk to their healthcare professional about discontinuing ^NDarvon-N^® and switching to alternative pain medicines. Any unused tablets should be returned to their point of purchase for disposal.

If you currently take ^NDarvon-N^®, you should:

• Talk to your healthcare professional if you have any concerns about ^NDarvon-N^®.
• Contact your healthcare professional right away if you experience an abnormal heart rate or rhythm or other symptoms including dizziness, lightheadedness, fainting or heart palpitations.
• Report any side effects with ^NDarvon-N^® to Paladin Labs Inc. or to the Canada Vigilance program. The contact information can be found in the box below.

Managing marketed health 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 case of serious heart rhythm abnormalities or other serious or unexpected adverse reactions in patients receiving ^NDarvon-N^® should be reported to Paladin Labs Inc. or Health Canada.

Paladin Labs Inc.
6111 Royalmount Ave., Suite 102, Montreal, Quebec H4P 2T4
Telephone: 1-888-550-6060

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    • Health Canada
    • Postal Locator 0701E
    • Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

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

Paladin Labs Inc. is committed to supplying you with high quality products and ensuring the highest level of patient care. Please do not hesitate to contact our Medical Services at 1-888-550-6060 if you need any additional information concerning this product recall and withdrawal.

Sincerely yours,

original signed by

Patrice Larose, B.Pharm., Ph.D.
Vice President, Scientific Affairs