HC Deb 10 June 1986 vol 99 cc145-6W
Mr. Key

asked the Secretary of State for Social Services whether the Committee on Safety of Medicines has completed its review of the available data on Reye's syndrome and aspirin; and if he will make a statement.

Mr. Hayhoe

The committee has been keeping under review for several years the question of a possible link between use of aspirin by children and Reye's syndrome (which is an extremely rare but very serious condition in children). During recent months the committee has been considering the latest results of further studies from the United States of America and the United Kingdom. On the basis of this new information, it has concluded that, while the causes of Reye's syndrome still cannot be defined with certainty, there is sufficient evidence that aspirin may be a contributory factor in some cases of Reye's syndrome in the United Kingdom for precautions to be taken.

The chairman of the Committee on Safety of Medicines has therefore written on 9 June to all doctors, dentists and pharmacists to advise that, on the evidence now available, aspirin should not be given to children under 12 except where the doctor considers it is necessary—for example, in the treatment of serious conditions such as juvenile rheumatoid arthritis. I am placing a copy of the letter in the Library.

In response to the committee's advice, and following discussions with my Department, the pharmaceutical industry has agreed to the following steps to prevent the general use of aspirin by children under 12:

  1. (a) immediately, to stop the supply of paediatric aspirin;
  2. (b) to sponsor a series of press announcements, starting this week, which will advise parents not to give aspirin to children under 12 years except on medical advice;
  3. (c) to include on the labels of all oral aspirin products the warning "Do not give to children under 12 unless your doctor tells you to." This changeover will be completed by manufacturers on, or before, the end of this year;
  4. (d) to supply family practitioner committees and health authorities with posters for display in GP surgeries, pharmacies and child health clinics.

The health departments are drawing the committee's advice to the attention of nurses working with children and families, health authorities, family practitioner committees, community health councils and local education and social services authorities. Officials from the medicines division of my Department are writing to companies holding product licences for aspirin products asking them to vary those licences to comply with the committee's recommendations.

I believe that these actions by the committee and the pharmaceutical industry together will ensure both immediate and continuing information is provided to the public about the possible risk to children under 12 from aspirin products, and will remove from the market very quickly aspirin products intended for children. I should like to join the committee in acknowledging the constructive and helpful manner in which the industry has reacted to the committee's latest advice.

The Government and the committee will continue to monitor very carefully both the use of aspirin by children and further information on the aetiology of, and possible risks from, Reye's syndrome, which I should stress is a very rare condition.