Dáil Éireann debate -
Tuesday, 15 Nov 1994

Vol. 447 No. 1

Ceisteanna—Questions. Written Answers. - Use of Drug.

Bernard J. Durkan

Question:

296 Mr. Durkan asked the Minister for Health if his attention has been drawn to public concern arising from the use of the drug Septrin/Co-trimoxazole; if he intends to initiate any changes with reference to prescribing through the General Medical Service; if there have been recordings of side effects from use of the drug in this country; and if he will make a statement on the matter. [3096/94]

Minister for Health (Mr. Howlin)

I would refer the Deputy to the reply which I gave in response to a similar question from him on 21 June 1994 regarding this preparation.

As I stated at that time I am aware of reports concerning the drug Co-trimoxazole which is an active ingredient in the preparation Septrin.

Septrin has been authorised in Ireland since 1975 with specific indications for use and is available only on prescription. Possible adverse reactions to the drug are well known and documented and there is nothing in recent reports which was not already known.

I am advised by the National Drugs Advisory Board that any cases of side effects which have been notified to the board suspected in association with Septrin and other Co-trimoxazole products have been published in the board's annual side effect listings which are circulated to medical practitioners, pharmacists and scientific libraries. The side effects which have been reported over the years are included in the product's published data sheet which has been revised and updated to reflect the drug's safety profile.

Although the possibility of adverse reactions in rare cases is known, the National Drugs Advisory Board, following the recent media reports, initiated further investigations into the safety of the drug and, in line with its normal pharmacovigilance procedures, continues to monitor the situation on an ongoing basis. The board, however, is satisfied that there is no cause for concern at this time.

Prescribers of the drug would be familiar with its indications for use and with any likely adverse reactions or contraindications to its use. It is not proposed to make any changes in relation to the requirements governing the prescribing of this drug.