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Restrictions on paracetamol planned

The Medicines Control Agency is proposing to limit packs of paracetamol on general sale to no more than 12 (500 mg or 120 mg) tablets or capsules and to limit pharmacy sale to no more than 30 tablets or capsules. The agency said that this should be sufficient for short term treatment in minor self limiting illness, but if patients have chronic or recurrent conditions pharmacists may be able to sell multiple packs up to a maximum of 100 tablets or capsules. The agency is inviting comments from professional and consumer bodies and manufacturers on the proposals.

Dr John Henry, consultant physician at the medical toxicology unit at Guy's and St Thomas's Hospital Trust, welcomed the proposals. "There is evidence to suggest that the number of overdoses is related to the ready availability of tablets in large quantities. We consider that a restriction of analgesic pack size would help to reduce the number of serious overdoses," he said.

To prevent disparities between comparable analgesics, it is proposed that pharmacy packs of aspirin should be limited to 30 (325 mg) tablets and packs on general sale to 12 tablets. Packs of ibuprofen on general sale will remain unchanged but limited to 30 tablets from pharmacies.

Dr Henry said that overdose with ibuprofen has become more common since it became available over the counter in 1983, but cases of serious poisoning remain rare. "There are documented cases of patients taking very large numbers of tablets as a single dose with full recovery," he said. Aspirin is now used less frequently as an analgesic but is more likely to cause adverse effects and is more dangerous in overdose than either paracetamol or ibruprofen.

The proposals also state that products containing paracetamol should also carry an additional label warning stating: "Immediate advice should be sought in the event of an overdose even if you do not feel unwell." Patient leaflets should also carry the statement: "Immediate medical advice should be sought in the event of an overdose because of the risk of serious liver damage."

Health minister Gerald Malone said: "Analgesics are extremely safe and effective when used in the recommended doses and conditions. However, there are real concerns about the dangers of overdose. For example, with paracetamol the symptoms of overdose might not readily be apparent. This creates a risk that people might delay seeking medical help."

The Medicines Control Agency is inviting comments on the proposals until 10 January and hopes to implement any changes by April 1997.--JACQUI WISE, BMJ

View larger version (121K): [in this window] [in a new window]   Paracetamol overdose kills over 150 people a year

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