Dáil Éireann Debate, Thursday - 10 February 2005
61 Caoimhghín Ó Caoláin asked the Tánaiste and Minister for Health and Children if her attention has been drawn to the fact that an arthritis treatment (details supplied) has been withdrawn in the United States; if she will order an immediate review of its use in this State; and if she will make a statement on the matter. [4158/05]
Amharc ar fhreagraThe Irish Medicines Board is the competent authority for the regulation of medicinal products in Ireland. The IMB assesses, on an ongoing basis, the quality, safety and efficacy of medicinal products.
I am advised by the board that this product has not been withdrawn in the United States but is undergoing review there. A similar review was undertaken by the European Medicines Agency which issued its findings on this matter in December 2004.
This review took into account new safety information on cardiovascular and serious skin adverse events in the use of this product. This information was communicated to health care professionals by the manufacturer concerned and via press statements which are available from the websites of the European Medicines Agency and the Irish Medicines Board.
The Irish Medicines Board will continue to monitor the safety, quality and efficacy of this product.
