Dáil Éireann díospóireacht -
Tuesday, 9 Mar 1999

Vol. 501 No. 6

Written Answers. - Amerscan Pulmonate II.

Jack Wall

Ceist:

259 Mr. Wall asked the Minister for Health and Children if he will give details regarding the withdrawal of Amerscan Pulmonate II from hospitals in which it was used in perfusion lung scans; and if he will make a statement on the matter. [7034/99]

Minister for Health and Children (Mr. Cowen)

In November 1997, following receipt of notification from the UK Medicines Control Agency, the Irish Medicines Board took steps, in co-operation with the distributors of the product, to ensure a full recall of relevant batches of the Amerscan Pulmonate II agent which was used in the diagnosis of abnormal lung perfusion in patients. As I have informed the House previously, the number of persons who received the withdrawn product in Irish hospitals was 460. Each of the nine hospitals involved was asked by my Department to identify all patients who were administered the product and to make arrangements to inform each person and to provide appropriate counselling.

The advice that I received from the CJD advisory group prior to taking the decision to inform patients was that the risk of transmission of new variant CJD through this product was unquantifiable but likely to be very low. The decision to inform patients was taken, on balance, following very careful consideration of the ethical issues involved having regard to the extremely low risk of transmission of the disease, the lack of a diagnostic test for new variant CJD, the lack of any treatment and the unknown incubation period of the disease. The extremely low level of risk involved was subsequently confirmed by the Committee for Proprietary Medicinal Products, CPMP, of the European Medicines Evaluation Agency (EMEA) in a position statement of 25 February last year on new variant CJD and plasma-derived medicinal products. It concluded that the transmission of new variant CJD by med icinal products derived from human blood or plasma is very unlikely.

All traceable recipients of the withdrawn Amerscan Pulmonate II product batches have now been contacted by the hospitals involved and have either had or been offered appointments for follow-up consultations with their treating physicians.