§ Mr. Ashleyasked the Secretary of State for Social Services (1) what discussions there have been with overseas drug regulatory agencies following his decision to recommend that aspirin should not be given to children;
(2) if the decision of the Committee on the Safety of Medicines that aspirin should not normally be given to children has been communicated to other drug regulatory agencies together with the evidence that led the committee to reach this conclusion.
§ Mrs. Currie[pursuant to her reply, 5 February 1987, c. 809–10]: The recommendation by the Committee on Safety of Medicines on the use of aspirin by children, together with a summary of the data considered plus details of subsequent United Kingdom action, were communicated to the World Health Organisation, the United States Food and Drug Administration, the Australian Regulatory Authority, all member states of the European Community and the Community's committee for proprietary medicinal products. There were full discussions with the World Health Organisation and other bodies concerned. A synopsis of the information and advice was also published as a CSM update, in the British Medical Journal, Vol. 292, June 1986, which has a worldwide distribution.
§ Mr. Ashleyasked the Secretary of State for Social Services whether he has requested aspirin manufacturers to warn on their labels that aspirin should not normally be given to children; and whether any such request applies to aspirin intended for overseas sale.
§ Mrs. Currie[pursuant to her reply, 5 February 1987, c. 809–10]: Following the recommendation by the Committee on Safety of Medicines in May 1986 about aspirin use by children, the pharmaceutical industry voluntarily agreed to place a label warning on all adult
601Waspirin products leaving its factories for use in the United Kingdom, that they should not be taken by children under 12 except on medical advice. We have no jurisdiction over products for overseas sale; the control of labelling is a matter for the regulatory authority concerned.