asked the Minister for Health if his attention has been drawn to the fact that medicines do not have their non-active ingredients listed; if his attention has been further drawn to the fact that this lack of adequate labelling can cause problems for people with food allergies as medicines frequently contain ingredients such as lactose and artificial colours which are common causes of food allergy; if he intends to take any steps to rectify this matter; and if he will make a statement on the matter.
Written Answers. - Medicine Labelling.
98.
I am aware that medical preparations do not at present have their non-active ingredients listed. The Medical Preparations (Advertisement and Sale) Regulations, 1958 as amended and the relevant EC Directives on Proprietary Medicinal Products do not currently require such listing.
In its examination of applications for product authorisations for medicinal products the National Drugs Advisory Board take account of the possibility of allergic reactions from the presence of non-active ingredients. The board take steps to have such ingredients removed where feasible or to inform the user of potential risks. This is done, in agreement with the applicant, by drawing attention to the presence of the non-active ingredients (which would include those artificial colouring agents which may cause an allergic reaction) on the label and/or the package insert.
The presence of lactose presents particular difficulties since it is present in almost all tablets. Persons with an allergy to lactose should where possible be supplied with the liquid dose forms which do not contain lactose.