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Drug troubles
Calgary Herald

On Dec. 22, 2004, Health Canada issued a statement warning Canadians about the safety concerns regarding a group of drugs knows as selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib) and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain). Health Canada says people taking these drugs should consider there is a strong possibility of an increased risk of cardiovascular events including heart attack and stroke.


This was withdrawn from the market on Sept. 30, 2004, based on new safety information from a three-year, randomized double-blind clinical trial showing a possible increased risk of cardiovascular events. Manufacturer is Merck & Co.


On Dec. 10, 2004, Pfizer released new information about cardiovascular risks associated with this drug. In a study conducted by the company, which included more than 1,500 patients treated for acute pain after coronary artery bypass grafting, an increased risk of cardiovascular events was observed in patients. Bextra is still available to patients.


On Dec. 17, 2004, the National Cancer Institute in the United States announced it had stopped a three-year Celebrex study due to an interim analysis showing a statistically significant increase in the risk of heart attack, stroke and cardiovascular death. Pfizer is the manufacturer of the drug. Celebrex is still available to patients.


Selective COX-2 inhibitor NSAIDs were first authorized for sale in Canada in 1999 based on data showing a better gastrointestinal safety profile than traditional (non-selective) NSAIDs (for example, ibuprofen). There was a need for new therapies because of the well-documented frequent and severe gastrointestinal adverse events -- ulcers and gastric hemorrhages -- associated with the use of traditional (non-selective) NSAIDs. Also, a significant number of patients could not tolerate them because of stomach upsets.

Source: Health Canada

© The Calgary Herald 2005

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