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Health Canada Revises Piroxicam Label

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A piroxicam safety review conducted by Health Canada has resulted in a labeling change for the drug in that country.  The revised Canadian piroxicam label will reflect an increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs, the agency said.

According to Health Canada, its safety review determined that the risks associated with the  use of piroxicam as a treatment for acute, short-term pain no longer 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).

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

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, Health Canada said.

Piroxicam is sold in the U.S. both generically, and under the brand name Feldene.

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