The UK Medicines Control Agency has recommended that children under 16 should not be given aspirin, because of its links with Reye's syndrome, the rare but potentially fatal disorder found almost exclusively in children and adolescents.
The use of aspirin in children under 12 has been banned in the United Kingdom since 1986, and in April this year the Committee on Safety of Medicines warned that it should also be avoided in children up to 15 if they were feverish.
But at its October meeting the committee concluded that its earlier advice was too complex for products available on general sale. This advice effectively required parents or children to diagnose fever. The committee has now recommended that the warning on aspirin products should read "Do not give to children aged under 16 years, unless on the advice of a doctor."
Chairman of the committee, Professor Alasdair Breckenridge, said, "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."
Reye's syndrome can affect all organs of the body, but it is most harmful to the brain and liver, where it may cause raised intracranial pressure or liver failure. A causal link between aspirin and Reye's syndrome has not been proved, and the exact causes of Reye's syndrome are not fully understood. However, since 1986 the condition has virtually disappeared in children aged under 12. Between 1981 and 1986 in the United Kingdom an average of nine cases a year were associated with aspirin use in this age group. Since mid-1986 only seven cases have occurred.
Cases have continued to occur, although rarely, in children aged over 12. Eleven cases were reported between 1986 and April 2002 in the United Kingdom. The latest was of a 13 year old girl who died earlier this year.
The Medicines Control Agency is launching an eight week public consultation to amend the regulations, and depending on the outcome the new warnings should come into effect in March 2003.
Professor Breckenridge added, "I want to be very clear that there is no cause for panic or concern, but I also want to ensure that parents and children alike are kept well informed and are aware of the importance of this warning."
In the United States the Food and Drug Administration recommends that aspirin should not be given to children under 19 years of age during episodes of fever.
The agency's statement on aspirin can be found at its website: http://www.mca.gov.ukwww.mca.gov.uk/