There is no evidence that the blood product Amerscan Pulmonate II is defective or that the British blood donor was suffering from the degenerative brain disease CJD at the time of the donation, the blood product manufacturers, Nycomed Amersham, claimed yesterday.
The manufacturers insisted that they had informed the Irish Medicines Board on the night of November 17th-18th that Amerscan Pulmonate II was to be recalled on the advice of the British Medicines Control Agency (MCA).
The blood product was recalled by the MCA as a "purely precautionary measure" in line with recommendations from the European Committee on Proprietary Medicine Products, a spokeswoman for the British Department of Health confirmed yesterday.
There were "concerns over the product", which is also being recalled from 98 hospitals in the UK, she added. However, the Department of Health refused to give details of the concerns. Patients in the UK who have received the blood product will not be informed about the withdrawal. "We feel that the risk is negligible, and there is no way of telling where CJD comes from and there is no treatment for the disease," the Department said.
Three batches of Amerscan Pulmonate II have been withdrawn in Ireland, and the corporate director of Nycomed Amersham, Mr Alan Huw Smith, said the company acted on the request to withdraw the product "immediately".
"The Medicines Control Agency contacted us on November 17th and we immediately contacted our distributors to recall and return the product. The MCA also contacted the Irish Department of Health at the same time. "If there was a delay between the Irish Medicines Board and the Irish Department of Health it is nothing to do with us," Mr Smith said.
The serum derived from the donor's blood, which was processed by the British National Blood Transfusion Service and sold to Nycomed Amersham, was recalled by the MCA on November 4th. The MCA then had its own internal debate with the European Committee on Proprietary Medicine Products about the products derived from the serum. The decision to recall Amerscan Pulmonate II was made on November 17th.
It is understood the withdrawal of Amerscan Pulmonate II from Ireland and the UK was completed in six days, but it is not known how many patients in the UK were receiving the treatment. It will be a "clinical judgment and choice" whether doctors decide to return the blood product, Mr Smith said. "They have not been told not to use it . . . the assessment of the risk is theirs, not ours. There is no indication that the product is contaminated. It was withdrawn as a purely precautionary measure."
Beaumont Hospital in Dublin has said that the blood product potentially infected with CJD was not administered to any of its patients.
In a statement, the hospital said it was anxious to inform all patients who had attended the hospital for lung scans that they had "no cause for concern", as Amerscan Pulminate II was not used in the hospital.