The Pharmaceutical Journal
Vol 268 No 7195 p557-561
27 April 2002

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Medicines Control Agency (www.mca.gov.uk)

Older children should also avoid aspirin

The Committee on Safety of Medicines has issued new advice on the use of aspirin in children. It now recommends that aspirin should be avoided in children aged 12 to 15 years if they are feverish. The advice for children below the age of 12 years — that they should not be given aspirin except on medical advice — still stands.

The labelling of aspirin-containing products is to be changed in light of the CSM advice. Products intended for use as an analgesic, antipyretic or anti-inflammatory will be labelled "Do not give to children under 12 years, and avoid up to and including 15 years of age if feverish". Aspirin-containing products indicated for the prevention of cardiovascular events in adults will be labelled "Not to be taken by children aged less than 16 years".

A spokesman for the Medicines Control Agency told The Journal that the proposed changes would be phased in, with companies changing their product information and packaging over a three- to six-month approval period. "The new advice is precautionary and builds on existing warnings and the changes will not involve wasting existing stocks of medicines. While it will take some time for new packing and existing stock to be consistent, a campaign is planned to raise awareness of the issue in advance of the next winter cold and 'flu season," he added.

The CSM advice, included in the latest issue of Current Problems in Pharmacovigilance (2002;28:4), is intended to reduce further the incidence of Reye's syndrome, which can be associated with aspirin use in children. Reye's syndrome is a rare metabolic condition leading to liver failure and brain damage.

The CSM says that since the mid-1980s the incidence of Reye's syndrome has declined markedly but that sporadic cases have continued to be reported. A number of the reported cases have been in children aged 12 years and over. All possible cases of Reye's syndrome at all ages should be reported to the CSM and Medicines Control Agency through the yellow card scheme.