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Updated Labeling for Piroxicam – Drug No Longer to be Used for Acute Pain or Inflammation


Riyadh, Jun 28,2009-, Health Canada, the Canadian counterpart to the Saudi Food and Drug Authority (SFDA), informing 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. The brand names of piroxicam available in Saudi Arabia are DISPERCAM , FELDENE , ORTHOCAM .

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 Saudi Arabia, 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.

Advice for doctors and patients:

Patients who have previously received piroxicam for ‘acute’ (short-term) use should receive an alternative medicine if they need similar treatment in the future.

Patients who are receiving piroxicam on a long-term basis for osteoarthritis, rheumatoid arthritis or ankylosing spondylitis should have their treatment reviewed at their next routine appointment. If appropriate, alternative treatment should be considered.

For all NSAIDs, the lowest effective dose should be used for the shortest period necessary to control symptoms.

Actions That Healthcare Professionals Should Follow :

The EMEA has recommended restrictions on the use of piroxicam-containing medicinal products because of the risk of gastrointestinal side effects and serious skin reactions. The Agency advises that piroxicam should no longer be used for short-term painful and inflammatory conditions, can be prescribed to relieve the symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, but should not be used as

a first-line treatment for these disorders.

Report Adverse Drug Reactions to the Saudi FDA

The public and health care professionals are encouraged to report adverse drug reactions of piroxicam to the National Pharmacovigilance center on the internet at: