Written answers

Tuesday, 6 March 2007

Department of Health and Children

Medicinal Products

11:00 pm

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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Question 323: To ask the Minister for Health and Children her views on recent medical concerns regarding the use of drug coated stents in the treatment of blocked arteries; the number of Irish patients who have undergone the procedure that is now the focus of these concerns; the measures taken to alert these patients to the potential hazards that are emerging regarding this treatment; and if she will make a statement on the matter. [8895/07]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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I am aware of the ongoing debate regarding the risks and benefits associated with the use of drug coated stents in treating blocked arteries. These are potentially life saving devices but, as with all implantable devices, they carry a degree of risk. The assessment of the risk against the benefits is made by the clinician or consultant responsible for the particular patient.

The Irish Medicines Board (IMB) is the statutory body responsible for the regulation of medicinal products and medical devices in Ireland. The IMB, in consultation with its European counterparts, has continuously monitored the safety of these products. At present, the European competent authorities are satisfied that the products are safe provided they are used correctly, in accordance with the manufacturers instructions and in line with the medical condition of the patient.

The number of Irish patients who have undergone the procedure is not available and information given to patients on risks associated with the use of stents is a matter for their medical practitioner or consultant.

The IMB and its European counterparts will continue to monitor the safety of drug coated stents licensed for use in Ireland; it will evaluate all new scientific data that emerge and will take any regulatory action necessary.

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