Overdose deaths lead to co-proxamol withdrawal
pharmafile | February 1, 2005 | News story | Sales and Marketing |Â Â Â
Co-proxamol, a commonly prescribed painkiller, will be withdrawn from use in the UK because of continued deaths from overdose.
The drug is a combination of paracetamol and the mild opiod painkiller dextropropoxyphene, used when paracetamol alone is not enough, and has been available since the 1960s.
The drug is available generically as co-proxamol and under the brand names Distalgesic, Cosalgesic and Dolgesic.
Stronger warnings about the dangers of overdose were added in 1985, but continued concerns have prompted the MHRA to order a phased withdrawal over the next 6 to 12 months.
The drug is associated with 300 to 400 intentional and accidental fatal overdoses annually, with 1.7 million patients receiving 7.5 million prescriptions of the drug in general practice every year.
MHRA chairman, 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."
A consultation with stakeholders on the drug was held last summer, which the MHRA say produced no new objective evidence concerning its risk/benefit ratio. The Royal Colleges and prescribing advisers were generally in favour of its withdrawal, while current prescribers and patients tended to support its continued use.
The MHRA added that there was little evidence that co-proxamol was more effective than normal paracetamol in the recommended dose, and said there were a number of alternative treatments for patients.
The government has set a target to reduce deaths from suicide and undetermined injury by at least a fifth by the year 2010 compared to the period 1995 to 1997, with a recent report by the National Institute of Mental Health in England (NIMHE) showing a fall of 6% so far.
