News: NICE launches guidance on COX-2 selective inhibitors

The Pharmaceutical Journal Vol 267 No 7159 p139-143
4 August 2001

NICE launches guidance on COX-2 selective inhibitors

The cyclo-oxygenase-2 (COX-2) selective inhibitors celecoxib (Celebrex), etodolac (Lodine SR), rofecoxib (Vioxx) and meloxicam (Mobic) should only be used to treat patients with rheumatoid arthritis or osteoarthritis who are at high risk of developing serious gastrointestinal (GI) problems, says the National Institute for Clinical Excellence.

In guidance issued last week, the NICE recommends that these four drugs should not be used routinely in patients with rheumatoid arthritis (RA) or osteoarthritis (OA) but that they should be reserved for “high risk” patients.

Patients considered by the NICE to be at high risk of developing serious GI adverse effects following NSAID therapy include:

those aged 65 years or over
those already taking other medicines that are known to increase the likelihood of GI complications
those with other serious co-morbidities
those who require long-term use of standard NSAIDs at their maximum recommended dose
those with a history of GI problems or with existing GI bleeding or gastroduodenal perforation

The NICE guidance states that all non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective inhibitors, should be prescribed only after careful consideration of their risks and benefits. It adds that long-term use of all NSAIDs should be avoided unless the patient is monitored and reviewed regularly.

The full guidance is available on the NICE website (www.nice.org.uk). A news feature in this week’s issue looks at the guidance in more detail.

No date has yet been set by the Department of Health for the review of the operations of the National Institute for Clinical Excellence. A spokesman for the department said that the matter was still with ministers. The Association of the British Pharmaceutical Industry has called for a fundamental review of whether the NICE is meeting its objectives.