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Saturday, 24 March 2012

MHRA alert on mislabelled high strength codeine in UK co-codamol batch

@HealthMed Co-codamol contains two types of painkiller. Paracetamol and the opiate drug codeine. The UK Medicines regulator, the MHRA, has warned that around 39,000 packets of these combination tablets have been issued to wholesalers and pharmacies, with the opiate codeine present in 4 times the strength on the label: 30mg instead of 8mg per tablet. The strength of the paracetamol in the tablets said to be unaffected. Lower dose codeine forms of co-codamol (in the UK 8mg or 12.8mg per tablet) are available over the counter in pharmacies. The higher dose codeine 30mg per tablet form of co-codamol is a prescription only medicine. This dose may be quite appropriately be prescribed by a doctor, after taking into account a patient's medical history and current drug treatment.
However codeine in high dose in at risk groups of patients is more likely to cause serious adverse effects such as drowsiness, confusion, and reduced respiratory drive and blood pressure. People at particular risk include the elderly, those with liver or kidney or lung disease, and people already on medicines known to cause these adverse effects. 
Codeine is a prodrug: it has to be converted in the body to its active forms (mainly to morphine) before it can be effective in relieving pain. Therefore people who are genetically able to activate codeine very rapidly are more likely to experience adverse effects when exposed to higher than expected doses of codeine.
High doses of codeine can also cause constipation as a troublesome adverse effect.
These 30mg strength codeine forms of co-codamol tablets have on them the mark "CCD30" on one side with "CP" on the second side.
As recommended by the MHRA, anyone concerned that they may have been incorrectly given the high strength co-codamol should contact their GP or pharmacist promptly. The reported batch number is LL11701, expiry date September 2014.

See also:
Reuters report
Daily Express report
New England J Med report on codeine intoxication associated with ultrarapid CYP2D6 metabolism

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