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MHRA Withdraws the Pain Killer Co-Proxamol

Jan 31, 2005 |

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of co-proxamol found that the benefits of the medicine did not outweigh the risks and that it should be gradually withdrawn from clinical use.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.â€

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that the benefits of the continued availability of co-proxamol do not outweigh the risks and that co-proxamol should be withdrawn from the market.â€

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.

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