Paladin Labs Inc.
TSX : PLB

Paladin Labs Inc.

December 01, 2010 11:11 ET

Paladin Labs Inc.: Recall and Withdrawal of Darvon-N® (Dextropropoxyphene) in Canada

Health Canada Endorsed Important Safety Information on Darvon-N®: Recall and Withdrawal in Canada

MONTREAL, QUEBEC--(Marketwire - Dec. 1, 2010) - In collaboration with Health Canada, Paladin Labs Inc. (TSX:PLB) has decided to voluntarily recall and withdraw all lots of Darvon-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 Darvon-N® and switching to alternative pain medicines. Any unused tablets should be returned to their point of purchase for disposal.

If you currently take Darvon-N®, you should:

  • Talk to your healthcare professional if you have any concerns about Darvon-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 Darvon-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 Darvon-N® should be reported to Paladin Labs Inc. or Health Canada.

Paladin Labs Inc.
6111 Royalmount Ave., Suite 102, Montreal, Quebec H4P 2T4
Tel.: 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 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  â—¦ Fax toll-free to 1-866-678-6789, or
  â—¦ 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php). 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

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

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

About Paladin Labs

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com

This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2009. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.

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