MJA Rapid Online Publication: Australian study estimates CJD risk after Lyodura use
A special online MJA article suggests that the rates of Creutzfeldt-Jakob disease (CJD) after the use of the dura mater patch Lyodura may be much higher in Australia than in other countries, such as Japan.
The dura mater is the tough outside membrane that covers the brain. Lyodura was commercially produced, processed dura mater, which was sourced from cadavers and used for patching in neurosurgery and some other surgical procedures.
In Australia, Lyodura was approved by the Therapeutic Goods Administration for importation and use in 1972. The product licence was withdrawn in early May 1987, shortly after recognition of the first case of CJD linked to Lyodura use.
As of January 2003, 120 cases of CJD related to dura mater use had been recognised worldwide.
Most cases (97) have occurred in Japan, giving an overall risk estimate of around 1 per 2,268 patients treated with Lyodura (0.04%) in that country.
In Australia, five cases of CJD have so far been linked to Lyodura, but the disease can take a long time to manifest itself, so further cases are possible.
To determine how much Lyodura might have been used in Australia, Fiona Brooke from the Communicable Diseases Branch of the Department of Health and Ageing joined researchers from the Australian National CJD Registry to examine past surveys of Lyodura use, then approached Lyodura's German manufacturers, B Braun Melsungen AG. The records are incomplete, but they estimate that about 2,500 people have possibly been exposed to Lyodura in Australia, making the risk of Lyodura-associated CJD higher in this country (around 0.2%) than in other countries that have undertaken similar investigations, such as Japan.
The article will not be included in the printed version of The Medical Journal of Australia. It will be available at www.mja.com.au on Thursday 15 January 2004.
A PDF version of the article is attached to this alert.
Publication
Lyodura use and the risk of iatrogenic Creutzfeldt-Jacob disease in Australia.
Fiona Brooke, Communicable Diseases Branch, Department of Health and Ageing, Canberra
Alison Boyd, Aust. National CJD Registry, Department of Pathology, University of Melbourne
Genevieve Klung, Aust. National CJD Registry, Department of Pathology, University of Melbourne
Colin Masters, Aust. National CJD Registry, Department of Pathology, University of Melbourne
Steven Collins, Aust. National CJD Registry, Department of Pathology, University of Melbourne
The Medical Journal of Australia is a publication of the Australian Medical Association.
CONTACT: Fiona Brooke, Dept Health and Ageing, 02 6289 8847 /0404 052 743
Judith Tokley, AMA Public Affairs, 0408 824 306 / 02 62705471