The Pharmaceutical Journal
Vol 270 No 7236 p214
15 February 2003

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Medicines Control Agency (www.mca.gov.uk)

Metrodin High Purity is recalled

All stocks of Metrodin High Purity (urofollitropin) are being recalled and the product is being permanently discontinued with immediate effect (see p221).

This follows advice from the Committee on Safety of Medicines that no medicinal products manufactured from human urine sourced from a country which has reported one or more cases of variant Creutzfeldt-Jakob Disease (vCJD) should be available in the United Kingdom.

The Department of Health says that Metrodin High Purity is manufactured from urine sourced from Italy and the withdrawal is purely a precautionary measure following confirmation of a case of vCJD in Italy. The Department says that there are adequate supplies of alternative products and that other urine-derived products on the market in the UK are not affected.

Professor Alasdair Breckenridge, chairman of the CSM, added: “There have been no reported cases of the transmission of CJD via urine or products from urine.” However, even a theoretical risk such as that associated with Metrodin High Purity is unacceptable given that there are alternative treatment, he said.