The following is a statement issued last night by the Department of Health:The Department of Health was made aware on November 26th, 1997, that the Irish Medicines Board had supervised the withdrawal from use in nine hospitals of three batches of Amerscam Pulmonate II agent. This is an injectable agent used by radiology departments in lung scans. The Department understands that approximately 270 patients are involved.
It was recalled by the Irish Medicines Board as a precautionary measure following confirmation that one of the blood donors in the UK whose plasma was used to manufacture the product subsequently developed new variant CJD. This product is manufactured in the UK and is purchased by hospitals through an Irish distributor of the UK company.
While there is no evidence that CJD has been transmitted by blood or blood products, this particular donor had the new variant of the condition and against this background recall of the product was seen to be a sensible precaution.
The Department of Health sought the advice of the CJD advisory group at its meeting on December 4th, 1997. The group identified a number of ethical and practical matters relating to this issue. The Department has been considering these matters and will shortly make arrangements for the recipients of this product to be informed in the most sensitive, prudent and sympathetic way possible. This will be the Department's focus in the next few days.
When all the relevant people have been contacted the Department of Health will make a further statement in the coming week.