Abstract
The analgesic co-proxamol (paracetamol/dextropropoxyphene combination) has been widely involved in fatal poisoning. Concerns about its safety/effectiveness profile and widespread use for suicidal poisoning prompted its withdrawal in the UK in 2005, with partial withdrawal between 2005 and 2007, and full withdrawal in 2008. Our objective in this study was to assess the association between co-proxamol withdrawal and prescribing and deaths in England and Wales in 2005-2010 compared with 1998-2004, including estimation of possible substitution effects by other analgesics. We obtained prescribing data from the NHS Health and Social Care Information Centre (England) and Prescribing Services Partneriaeth Cydwasanaethau GIG Cymru (Wales), and mortality data from the Office for National Statistics. We carried out an interrupted time-series analysis of prescribing and deaths (suicide, open verdicts, accidental poisonings) involving single analgesics. The reduction in prescribing of co-proxamol following its withdrawal in 2005 was accompanied by increases in prescribing of several other analgesics (co-codamol, paracetamol, codeine, co-dydramol, tramadol, oxycodone, and morphine) during 2005-2010 compared with 1998-2004. These changes were associated with major reductions in deaths due to poisoning with co-proxamol receiving verdicts of suicide and undetermined cause of -21 deaths (95% CI -34 to -8) per quarter, equating to approximately 500 fewer suicide deaths (-61%) over the 6 years 2005-2010, and -25 deaths (95% CI -38 to -12) per quarter, equating to 600 fewer deaths (-62%) when accidental poisoning deaths were included. There was little observed change in deaths involving other analgesics, apart from an increase in oxycodone poisonings, but numbers were small. Limitations were that the study was based on deaths involving single drugs alone and changes in deaths involving prescribed morphine could not be assessed. During the 6 years following the withdrawal of co-proxamol in the UK, there was a major reduction in poisoning deaths involving this drug, without apparent significant increase in deaths involving other analgesics.
Highlights
In January 2005, following a review of the effectiveness and safety profile of the analgesic co-proxamol by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK Committee on Safety of Medicines (CSM) announced that the drug should be withdrawn from use in the UK, the final date of withdrawal being 31st December 2007
During the 6 years following the withdrawal of co-proxamol in the UK, there was a major reduction in poisoning deaths involving this drug, without apparent significant increase in deaths involving other analgesics
Deaths Quarterly data on drug-poisoning deaths involving co-proxamol, cocodamol, codeine, co-dydramol, dihydrocodeine, non-steroidal anti-inflammatory drug (NSAID), paracetamol, and tramadol based on death registrations during 1998– 2010 in England and Wales were provided by the Office for National Statistics (ONS)
Summary
In January 2005, following a review of the effectiveness and safety profile of the analgesic co-proxamol by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK Committee on Safety of Medicines (CSM) announced that the drug should be withdrawn from use in the UK, the final date of withdrawal being 31st December 2007. Where the chronic pain was progressive, for example cancer, more potent opioids (e.g., morphine, oxycodone) could be considered [1] The background to these steps was longstanding concern about the extent of fatal self-poisoning with co-proxamol [3,4]. Between 1997 and 1999, the prescription analgesic (pain killer) co-proxamol, which contains paracetamol and the opioid dextropropoxyphene, was implicated in a fifth of drug-poisoning suicides in England and Wales. In response to concerns about coproxamol’s widespread use for suicidal poisoning and its safety/effectiveness profile, the UK Committee on Safety of Medicines announced on January 31, 2005 that the drug would be withdrawn completely from use in the UK by December 31, 2007, and that between 2005 and 2007, doctors should not prescribe co-proxamol to any new patients and should try to move patients already taking the drug onto other medications
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