MHRA Withdraws Pain Killer Co-Proxamol, UK

Main Category: Pain / Anesthetics
Article Date: 31 Jan 2005 - 15:00 PDT


A phased withdrawal of the commonly prescribed painkiller, co-proxamol, was announced today by the Medicines and Healthcare products Regulatory Agency.

A recent consultation looking at evidence for the safety and effectiveness of co-proxamol found that the benefits of the medicine did not outweigh the risks and that it should be gradually withdrawn from clinical use. Co-proxamol is associated with 300-400 intentional and accidental fatal overdoses each year.

The Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff said:

"Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative. There is no need for panic or concern and if patients have been taking co-proxamol continuously for a long time they should not stop without consulting their doctor."

The Chairman of the Medicines and Healthcare products Regulatory Agency (MHRA), Sir Alasdair Breckenridge said:

"Whilst the risks of co-proxamol are well known to health professionals, the latest evidence is that the measures to strengthen the labelling of co-proxamol have been ineffective in reducing the high fatality rate involving both intentional and accidental overdose. The MHRA and CSM have considered further evidence gathered during a public request for information on the risks and benefits of co-proxamol and have decided that the benefits of the continued availability of co-proxamol do not outweigh the risks and that co-proxamol should be withdrawn from the market."

Co-proxamol is available only on prescription and contains a combination of paracetamol and dextropropoxyphene. It is estimated that 1.7 million GP patients per year receive 7.5 million prescriptions for co-proxamol.

NOTES TO EDITORS

1.) The CSM is an independent Committee of experts that advises Government on the safety, quality and effectiveness of medicines, including vaccines. It is also responsible for encouraging the collection and investigation of reports on suspected adverse reactions to medicines already on the market. The MHRA is the executive arm of the UK's Drug Licensing Authority and is responsible for all aspects of the regulation of medicines in the UK.

2.) The National Institute of Mental Health in England (NIMHE) is an organisation set up by the Department of Health aimed at improving the quality of life for people of all ages who experience mental distress. A key goal of the NIMHE's National Suicide Prevention Strategy is to reduce the number of suicides as a result of overdose. Reduction of access to means of suicide has been identified by NIMHE as an effective method of achieving this goal (www.nimhe.org.uk)

3.) Media enquiries only to Alison Langley on 0207 210 5649 or Vicky Wyatt on 020 7210 5656.

GNNREF: 110013
Issued by : DOH Press Office

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