WHO Pharmaceuticals Newsletter 2004, No. 04
(2004; 14 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentALOSETRON - Risk management plan to remain in place
View the documentANTIDEPRESSANTS - Health Canadaendorsed safety information
View the documentBUPROPION - Labelling updated to include class warning
View the documentCLOZAPINE - Labelling to include updated patient safety registry information
View the documentDEXTROPROPOXYPHENE/PARACETAMOL - Prescribing reminder
View the documentDOMPERIDONE - Not to be used to increase milk production in women
View the documentLEFLUNOMIDE - Update on interstitial lung disease
View the documentROSUVASTATIN - Higher dose and predisposing factors linked with rhabdomyolysis
View the documentSULPHUR HEXAFLUORIDE - Use in echocardiography suspended
Open this folder and view contentsSAFETY OF MEDICINES
View the documentANNOUNCEMENT
 

DEXTROPROPOXYPHENE/PARACETAMOL - Prescribing reminder

UK. Due to the established toxicity in overdose and poorly defined clinical value of the pain reliever dextropropoxyphene/paracetamol (Co-proxamol), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is reminding physicians to observe the following:

• restrict the number of tablets prescribed and avoid prescribing dextropropoxyphene/ paracetamol (Co-proxamol) to patients at risk of self-poisoning or with a history of alcohol abuse

• advise patients that the medication is for their use only and can be dangerous when taken with alcohol or central nervous system (CNS) depressants and that unused tablets should be destroyed or returned to a pharmacy

• inform patients that they should receive a patient information leaflet and ask for one if they do not


According to the MHRA the rationale for the extensive use of the combination of dextropropoxyphene (32.5mg) and paracetamol (325mg) (Co-proxamol) is not evidence based; dextropropoxyphene is a weak analgesic and combining it with paracetamol has not been shown to have greater efficacy than full strength paracetamol. This combination product (Co-proxamol) is currently under review and is the subject of a public request for information.

Reference:

Medicines and Healthcare products Regulatory Agency (MHRA) News, 30 June 2004. Available on the Internet at www.mhra.gov.uk

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Last updated: May 3, 2013