Dáil Éireann - Volume 592 - 17 November, 2004

Written Answers. - Medicinal Products.

  158. Mr. Allen asked the Tánaiste and Minister for Health and Children if she will make a statement on the matter of concerns in relation to a drug (details supplied) that were identified at a meeting in Tunisia in 2002; if her attention has been drawn to these concerns; and the actions that were taken. [29018/04]

  Ms Harney: The safety of this product has been closely monitored, both nationally and at European level, since its first authorisation in the EU in 1999. The potential for the development of cardiovascular adverse effects has been known for some time and these effects were highlighted in the patient information leaflet that accompanied the product. On 1 October 2004, the manufacturer voluntarily withdrew the product from the market worldwide: this withdrawal was undertaken on the basis of data from one new clinical trial which indicated that refecoxib, the active ingredient in the product, was associated with an increased risk of cardiovascular side effects. The Irish Medicines Board, in conjunction with the company concerned, notified health care professionals in this country and co-ordinated the recall of stocks.