BSR Statement on the EMEA Review of COX II Inhibitors

The British Society for Rheumatology has been informed of the announcement made by the European Medicines Agency (EMEA) that it has agreed on a number of urgent regulatory actions as part of its ongoing review of the class of drugs known as Cox II inhibitors. These are interim measures pending the finalisation of their class review expected in April 2005.

This announcement follows concerns that some of these drugs may put patients at an increased risk of having a heart attack or a stroke. It has been concluded that although Cox II drugs do exist in different subclasses the possibility of similar side effects that other drugs in the class may present cannot be excluded.

This decision does of course have implications for those patients who have found the treatment to be of great benefit to their condition in the past five years.

The EMEA’s decision clearly places extra responsibilities upon both rheumatologists and general practitioners trying to prescribe effective and safe drugs in consultation with their patients who have arthritis. We would suggest the following points should be taken into consideration:

1. The BSR strongly recommends that all patients who have been taking these drugs consult their general practitioner or rheumatologist as soon as possible with a view to finding alternative medication as appropriate.
2. Every doctor from general practitioner to specialist should be as sure as possible that a non-steroidal anti-inflammatory drug, as opposed to an analgesic, is actually required. An assessment should be made in every case to ascertain whether an individual patient does indeed have particular risk factors for the development of side-effects, notably gastrointestinal effects, but also renal and respiratory side-effects. The urgent safety restrictions which the EMEA has published should be referred to for further guidance. There is a separate statement on the EMEA website which details the contradictions and warnings that it has introduced.
3. In patients in whom there is a clear need for a non-steroidal anti-inflammatory drug in spite of one of the contraindications, it will clearly be essential to co-prescribe one of the various drugs offering gastric protection.

The society would recommend that those looking for further guidance should see the advice produced by the EMEA which can be found at: http://www.emea.eu.int/home.htm

For more information please contact Lizzie Bloom, Policy Officer on 020 7242 3313 or lbloom@rheumatology.org.uk