The Pharmaceutical Journal
Vol 269 No 7221 p593
26 October 2002

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OTC aspirin ban likely to be extended to all under 16s

Restrictions on the use of aspirin are to be further tightened, the Medicines Control Agency announced this week. All aspirin products will be required to carry a warning that children under 16 years of age should not take aspirin unless specifically advised to do so by a doctor.

Reye’s syndrome Reye’s syndrome is a rare brain and liver disorder than can be fatal. It is found almost exclusively in children and occurs mainly in those under the age of five years. A small number of cases have been reported in children aged six to 11 years. It is extremely rare among older children.

The announcement follows earlier recommendations from the Committee on Safety of Medicines that aspirin should be avoided in children aged up to and including 15 years if they are feverish and that the ban in under-12-year-olds should remain (PJ, 27 April, p557). These restrictions were thought to be necessary because of the small risk of Reye’s syndrome among 12- to 15-year-olds who have a fever and who take aspirin (see Panel). However, the CSM reviewed its recommendations at its October meeting and decided that because aspirin products are on general sale the advice was too complicated.

Professor Alasdair Breckenridge, chairman of the CSM, said: “The risk of Reye’s syndrome in 12- to 15-year-olds is small but there have been concerns that earlier advice was too complex for products that are available on general sale — in the supermarket and corner shop — requiring a diagnosis of fever by a parent or minor.

“There are plenty of analgesic products containing paracetamol and ibuprofen for this age group not associated with Reye’s syndrome. There is simply no need to expose those under 16 to the risk, however small.” He added that parents and children should talk to a pharmacist if they have any questions.

The MCA has launched an eight-week public consultation on the proposed changes to warnings for aspirin products. The full consultation document is available on the MCA website (www.mca.gov.uk). Comments can be sent to Jeremy Mean, MCA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, by 31 December.

Subject to the outcome of this consultation, the MCA says that a statutory instrument will be laid before Parliament with the requirement for new warnings coming into force around March 2003.