New NSAIDS recommended for restricted use
PEOPLE with arthritis considered to be at high risk of developing stomach ulcers and other complications will be routinely prescribed the new COX-2 drugs, after a ruling by the National Institute for Clinical Excellence (NICE).
But NICE ruled out making COX-2s available for routine use in other people with osteo or rheumatoid arthritis.
The four drugs which will now be more widely available for high risk groups are celecoxib (Celebrex), rofecoxib (Vioxx), etodolac (Lodine SR), and meloxicam (Mobic).
People regarded as being at high risk are those aged 65 or over, those already taking other medicines which can cause gastrointestinal problems, and those with existing problems.
NICE also recommended that because all non-steroidal anti-inflammatory drugs (NSAIDs) can cause side effects they should only be prescribed when there is demonstrable clinical need. Long-term use should be avoided, it added, unless the patient was monitored and their condition regularly checked.
All NSAIDS can cause side effects such as stomach ulcers or bleeding, perforations in the stomach or intestine. The old COX-1 type NSAIDs are estimated to cause the deaths of 2,000 people in the UK and hospitalise a further 12,000. The newer COX-2s main selling point is that they cause fewer gastrointestinal complications.
Many doctors have expressed concern at the large number of NSAIDs routinely prescribed for arthritis despite the risk of serious side effects. However, the cost of prescribing COX-2 drugs for patients of all age and risk groups would have been an extra £100m, according to NICE chief executive Andrew Dillon.
Three drug companies which manufacture COX-2s, Pharmacia, Pfizer and Merck Sharp and Dohme appealed against the NICE ruling to allow restricted access only, but their appeal was rejected.
NICE said that while big claims were made of the advantages of the COX-2s, further research was needed to establish their value. There was a paucity of good quality head to head trials of the four different products, and of cost effectiveness studies, it added.
Celecoxib, meloxicam, and etodolac are prescribed for both OA and RA, while rofecoxib is prescribed only for OA.
