Vol. 441 No. 3
8 Mrs. T. Ahearn asked the Minister for Health the safety of the medication known as glucophage for diabetics and in particular for a person (details supplied) in County Tipperary; his views on the assessment of the medication published in Balance magazine; and if he will make a statement on the matter.
The preparation Glucophage (Metformin) has been authorised for use in the treatment of diabetes since 1979, having been assessed by the National Drugs Advisory Board which was satisfied with regard to the quality, safety and efficacy of the product. The assessment of the medical preparation in Balance magazine does not differ from facts known to the National Drugs Advisory Board.
Patients would only be placed on this treatment after having been assessed by an appropriate medical specialist and would be kept under regular medical surveillance to allow for the early detection of any possible adverse factors.
As diabetes is a condition that requires the attention of an appropriate specialist it would not be proper for me to comment on suitability of this medication in the specific case referred to by the Deputy. However, should the individual concerned have any anxieties in relation to this medication, he should immediately consult with his doctor in the matter.
Has any follow-up research been carried out in respect of patients who may have been prescribed the drug to ascertain if there are any adverse effects or trend established?
The licensing of drugs is a matter for the National Drugs Advisory Board. They are the experts and inform me if a particular product is safe and effective and of the highest quality. I am informed by the board that this product satisfies those criteria.
I try to avoid repetition, but the Minister has not responded to my question. Perhaps I did not make myself clear. Has he asked the National Drugs Advisory Board to indicate whether patients who have been given this product have shown any ill effects or if any trends have been established, other than those in respect of which warnings were already published?
At the risk of repeating myself, it is the responsibility of the National Drugs Advisory Board to license and monitor a product. It licensed this product in 1978 and its authorisation has been renewed and evaluated regularly since then. The latest data I have is dated 29 March and it has received no reports of lactic acidosis in association with the product.
I have asked the question twice in a different fashion and the Minister has still not answered it. Can he obtain this specific information?
What question is the Deputy asking?
Has the Minister any information from the National Drugs Advisory Board as to how the patients who were prescribed the drug have been affected by it and have any of the ill effects mentioned in Balance magazine been manifest?
I have already answered the question, but I will answer it again. The article referred to the condition lactic acidosis and the National Drugs Advisory Board informed me on 29 March that as of that date it had received no reports of lactic acidosis in association with the product.
I hope it has adequately checked the position.
