(2005; 12 pages)
PARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
UK. The UK Medicines and Healthcare products Regulatory Agency (MHRA), under advice from its Committee on Safety of Medicines (CSM), has announced the withdrawal of the paracetamol-dextropropoxyphene combination product (co-proxamol) in the UK. The CSM undertook a recent review of the risks and benefits of co-proxamol and has concluded that the efficacy of co-proxamol is poorly established and that the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.
Co-proxamol contains paracetamol (325 mg) and the weak opioid analgesic dextropropoxyphene (32.5 mg). Each year 300-400 fatalities involving co-proxamol are known to occur in England and Wales following deliberate or accidental overdose. Approximately one-fifth of these deaths are considered to be accidental.
The CSM has announced that, in order to minimize disruption of healthcare provision, co-proxamol will be phased out so that patients currently receiving co-proxamol may be switched to alternative pain management regimes at their next routine medication review. The CSM has issued the following interim prescribing advice, pending withdrawal of co-proxamol:
• Co-proxamol is only indicated in the treatment of mild to moderate pain in adults where first-line analgesics have proved ineffective or are inappropriate. It should not be used for any acute pain management.
• Co-proxamol therapy should not be initiated in new patients.
• Co-proxamol should not be used in patients aged <18 years.
• Co-proxamol is contraindicated in patients who are alcohol-dependent, who are likely to consume alcohol whilst taking co-proxamol, and in those patients who are suicidal or addiction prone.
Letter from the Chairman, UK Committee on Safety of Medicines, 31 January 2005. Available on the Internet at www.mhra.gov.uk