Updated Labelling for Piroxicam - Drug No Longer to be Used for Acute Pain or Inflammation

Information Update
2009-102
June 25, 2009
For immediate release

OTTAWA - Health Canada is informing Canadian health care professionals and consumers of recent restrictions regarding the use of the prescription drug piroxicam. Health Canada has conducted a safety review and concluded that piroxicam should no longer be used to treat short-term pain and inflammation due to an increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs.

Piroxicam is a prescription drug in the family known as non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and is used to relieve pain and inflammation.

Health Canada's review determined that the risks associated with its use as a treatment for acute, short-term pain outweigh the benefits relative to other non-selective NSAIDs. Piroxicam can still be prescribed for the symptomatic relief of chronic pain and inflammation in patients suffering from certain types of chronic arthritis (osteoarthritis, rheumatoid arthritis and ankylosing spondylitis).

In Canada, there are several alternative drugs, including other non-selective NSAIDs that can be used to treat acute, short-term pain and inflammation. The choice of an alternative medicine will depend on the type of pain being treated and should be determined in consultation with a health care professional.

This new safety information affects the product labelling only for piroxicam drugs that are indicated for the treatment of acute pain. Health Canada is currently working with the manufacturers of these drugs to revise the product monographs. Patients with concerns should contact their physicians.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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

• Report online at the MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this website.

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Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709