A recent article from a French/American/Canadian team of researchers explains detection of prion protein in a number of urine-derived hormonal preparations for the treatment of female infertility [1]. A Japanese team of researchers has previously made similar findings [2]. Contrary to the Japanese study, the new study also includes products relevant to Denmark.
Prions are naturally occuring proteins. Unlike ordinary prion protein, abnormal variants have been associated with causing Creutzfeldt–Jakob disease, which is a rare brain disorder. The two above-mentioned studies have not shown any sign of abnormal variants of prion protein, and a link between ordinary prion protein and infection with Creutzfeldt–Jakob disease has never been established.
In addition, a link between the use of urine-derived medicines and Creutzfeldt–Jakob disease has never been documented. This should be viewed in the light of the comprehensive, long-standing use of these medicines worldwide.
Based on the currently available data, including the results from the new study, the Danish Medicines Agency still assesses that there is no reason for discouraging the use of urine-derived hormonal preparations.
The Danish Medicines Agency will keep a close eye on development
In the Danish Medicines Agency, we will monitor development closely and probably align our recommendations closely with the ones of common European expert groups and advisory bodies.
We are aware that the article has already been discussed in an expert group with specific expertise on Creutzfeldt–Jakob disease under the Biologics Working Party (BWP) of the European Medicines Agency (EMA).
The subject will be discussed again at the European Medicines Agency in the near future. Presumably, already in May with the participation of Denmark.
On account of the article, the Danish Medicines Agency has contacted the manufacturer of the products which are relevant to Denmark and requested their comments.
