Request for further evidence on the risks and benefits of analgesic co-proxamol

Main Category: Public Health
Article Date: 30 Jun 2004 - 16:00 PDT

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The MHRA today issued a request for any further evidence about the risks and benefits of the painkiller co-proxamol, as part of an ongoing review being carried out by Committee on the Safety of Medicines (CSM). Co-proxamol is available only on prescription and contains a combination of paracetamol and dextropropoxyphene.

Prescribers are aware of the serious risks to patients who exceed the recommended dose on co-proxamol, whilst there is little evidence that co-proxamol is more effective in treating pain than normal paracetamol in the recommended dose.

The CSM first reviewed co-proxamol in 1985 and advised that health professionals should be reminded of the potential risks of overdose as well as clearer information being included in the Patient Information Leaflet. However, the evidence shows that these measures have not been effective in reducing deaths. Co-proxamol is still associated with 300-400 accidental and intentional fatal overdoses each year.

In view of this, and in support of the National Suicide Prevention Strategy, MHRA is asking for any further evidence of the safety and efficacy of co-proxamol, in particular to identify any patient groups in whom the risk:benefit balance is positive.

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 would like to consider any further evidence on the risks and benefits of co-proxamol to decide whether any further action is needed. Whilst this review is ongoing, prescribers are being reminded again on ways to minimise the risk of fatal overdose."

Notes to editor

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 (http://www.nimhe.org.uk)

3.)The MHRA's letter requesting further information is available on the MHRA website (www.mhra.gov.uk) and any replies and supporting information you may have should be sent to Amanda Lawrence, at the MHRA to arrive by 17 September 2004.

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