Risk/benefit of of Co-proxamol, prescribing reminder, UK

Main Category: Alcohol / Addiction / Illegal Drugs
Article Date: 30 Jun 2004 - 24:00 PDT

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300-400 people in England and Wales die each year following deliberate or accidental overdose with co-proxamol (Distalgesic; Cosalgesic; Dolgesic), a fixed combination of paracetamol (325mg) and the weak opioid analgesic, dextropropoxyphene (32.5mg) indicated for the treatment of mild to moderate pain. Combination with alcohol or CNS depressants is particularly hazardous and may cause fatal apnoea or cardiac arrhythmia.

The rationale for the extensive use of this combination product is not evidence based; dextropropoxyphene is a weak analgesic and co-proxamol has not been shown to have greater efficacy than full strength paracetamol. In view of its well-established toxicity in overdose and poorly defined clinical value, the role of co-proxamol is currently under review and is the subject of a public request for information (details are available on the MHRA website www.mhra.gov.uk).

In order to reduce the risk of fatal self-poisoning with co-proxamol, prescribers are reminded to:

-- RESTRICT the number of tablets prescribed at any one time to the smallest quantity necessary for the condition being treated.

-- AVOID prescribing co-proxamol for patients who are believed to be at risk of self-poisoning or those with a history of alcohol abuse.

-- ADVISE patients that the tablets are for their use only; the recommended dose must not be exceeded; that the drug can be extremely dangerous if taken with alcohol or CNS depressants and that unwanted tablets should be destroyed or returned to a pharmacy.

-- INFORM patients that they should be given a patient information leaflet at the point of dispensing and to ask for one if it is not offered.

Review of the pain reliever Co-proxamol (Distalgesic; Cosalgesic; Dolgesic) and request for evidence on risk and benefits (106KB)

Letter reply form (24KB)

Question and Answer: Co-proxamol: review of the risks and benefits (19KB)

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