Piroxicam Label in Canada to be Revised
On June 25, 2009, Health Canada, an organization similar to the FDA, announced new restrictions fro Piroxicam. The agency concluded that piroxicam should no longer be used to treat short-term pain and inflammation because of 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 risks associated with its use as a treatment for acute, short-term pain do not outweigh the benefits relative to alternative treatment options. Piroxicam should still be used for chronic pain and inflammation in patients suffering from certain types of chronic arthritis.
The product’s labeling will be updated to reflect the new restrictions. Health Canada is currently working with the manufacturers of these drugs to revise the product monographs. Patients with concerns should contact their physicians.
The FDA made a similar announcement regarding all NSAIDs in May 2009.
Please report any adverse reactions associated with Piroxicam to the FDA.
The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.htm