asked the Minister for Health if he is satisfied with the system for monitoring drugs that are widely prescribed; if he will inform the House of the procedures for monitoring the adverse effects of drugs particularly with respect to drugs that are not new; if he is aware that two recent studies have shown that the contraceptive pill gives rise to an increased risk of hepatocellular carcinoma in women using the drug for eight years or more; if he is satisfied that women currently taking the contraceptive pill are adequately advised about the risk of cancer associated with this drug; if he is satisfied that women taking this drug are adequately advised about its other side effects; if he will inform the House of the possible side effects of the contraceptive pill as known to his Department; if he will provide statistics regarding the number of women who have suffered adverse side effects from the contraceptive pill during the years 1980 to 1985, inclusive; and if he intends to make a regulation requiring the manufacturers of this drug to list on the packet all of the known side effects of this drug.
Written Answers. - Monitoring of Drugs.
I am satisfied with the system currently in operation for the monitoring of drugs in this country. The procedure for monitoring adverse effects of drugs is operated by the National Drugs Advisory Board on the basis of reports in standard form supplied by doctors, dentists and pharmacists. Where necessary, these reports are followed up with the doctors concerned. There are special monitoring arrangements in respect of congenital abnormalities and their possible association with medicines.
I am aware of the recent studies referred to by the Deputy, the results of which have been taken into account in deciding upon the precautions and warning statements for product leaflets which are required as a condition of the product licences issued by my Department. Because of these licensing arrangements, specific regulations are not necessary to require a listing of side effects on packets.
As the Deputy is no doubt aware, these products are available only on prescription, which ensures that women have specific advice of a medical practitioner in addition to the printed information provided by the manufacturer in relation to risks and side effects.
The more common side effects associated with the use of the contraceptive pill include headache, gastrointestinal upset, candidiasis, depression, thrombophlebitis, hypertension, breakthrough bleeding, weight changes, fluid retention, amenorrhoea, cleasma, breast changes.
Side effects reported to the National Drugs Advisory Board in respect of the contraceptive pill during the years 1980 to 1985 inclusive totalled 110. This information is included in the general reports of side effects associated with the use of drugs which are published by the National Drugs Advisory Board each year and circulated to all doctors, dentists and pharmacists.