§ Mr. Ashleyasked the Secretary of State for Social Services (1) what American and British evidence was considered by the Committee on Safety of Medicines when it looked at the possibility of an association between 167W Reye's syndrome and the taking of aspirin by children; at how many meetings the possible association was discussed; if the opinions of the American Food and Drugs Administration were sought; what are the conclusions of the Committee; and if they differed from those of the Food and Drugs Administration;
(2) if the Committee on Safety of Medicines has considered the possibility of an association between Reye's syndrome and the taking of aspirin by children in the light of the pilot epidemiological study on Reye's syndrome, published in December 1984 by the Centre for Disease Control in Atlanta, United States of America; and if he will make a statement on the advisability of children taking aspirin.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines considered the possibility of an association between Reye's syndrome and aspirin ingestion at its September 1982 meeting. They considered all the available evidence, in particular the reports of three epidemiological studies in the United States of America and reviews of this work by the United States Food and Drugs Administration and other bodies in the United States; and articles in the USA publication "Paediatrics".
The committee also looked at two investigations in the United Kingdom into Reye's syndrome; a national childhood encephalopathy study and a continuing surveillance scheme set up jointly by the British Paediatrics Association and the Communicable Disease Surveillance Centre. At that time the committee had received no reports through its adverse reactions reporting system suggesting an association between Reye's syndrome and aspirin ingestion. It has since received one such report.
The committee concluded that, on the available evidence, a causal link between aspirin and Reye's syndrome had not been established. The committee noted that the United States Surgeon General of the Public Health Service, on the basis of the US evidence,
intended to advise that children with influenza or chicken pox should not be given salicylates and salicylate-containing medicationsbut decided that it did not wish to recommend such action in the United Kingdom. It further decided to keep the issue of Reye's syndrome and aspirin under review.The committee is currently considering a summary of preliminary findings of a pilot study by a United States Public Health Service task force, which included members of the Centre for Disease Control, Atlanta. A report of the pilot study has not so far been published. When we have considered the committee's advice on the up-to-date evidence, we shall decide whether any statement is needed on the position in the United Kingdom.