WITHDRAWAL OF METRODIN HIGH PURITY (HP)

10 Feb 2003 02:15 PM

The Committee on Safety of Medicines (CSM) has advised that Metrodin High Purity (HP) should no longer be used in the UK.

Metrodin HP is used predominantly for strong stimulation of the ovary in women undergoing in vitro fertilisation (IVF) or, less frequently, in women who have a hormonal deficiency leading to a failure to ovulate. More rarely, it is used to treat men with a hormonal deficiency that affects the production of sperm.

The Committee's advice is based on the precautionary principle that products manufactured from human urine sourced from a country with one or more cases of variant Creutzfeldt-Jakob Disease (vCJD), should not be used whenever practicable.

Metrodin HP is manufactured from urine sourced from Italy, and the withdrawal of Metrodin HP is a purely precautionary measure following the confirmation of a case of vCJD in Italy. There are adequate supplies of alternative products. Other urine-derived products on the UK market are not affected.

Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines said:

"CSM has advised the withdrawal of Metrodin HP purely as a precautionary measure. The Committee carefully considered this issue and advised that even a theoretical risk such as that associated with Metrodin HP was unacceptable given that there are alternative treatments. It is stressed that there have been no reported cases of the transmission of CJD via urine or products derived from urine."

Following discussions with the Medicines Control Agency, the manufacturer Serono has started the withdrawal and has sent a letter to all doctors who use Metrodin HP. Any women who are currently undergoing treatment with Metrodin HP should discuss with their doctors whether to switch to another product during the treatment cycle.

Any women who are concerned about their treatment can also contact NHS Direct on 0845 4647

The CSM continually reviews the safety of medicines that are prepared from human and animal materials, particularly with respect to any potential risk from transmissible spongiform encephalopathies. Due to the number of cases of vCJD that have occurred in the UK, the CSM has recommended as a precautionary measure that human blood plasma sourced from the UK not be used to prepare medicines. This precautionary principle has since been logically extended to cover any country where at least one case of vCJD has arisen. Following consideration of a publication reporting that an abnormal prion protein has been identified in urine of CJD patients, CSM advised that the same precautionary principle that is in place for plasma should apply to urine.

Notes to Editors

1. The Committee on Safety of Medicines is an independent expert scientific committee, which advises the Government on Medicines.

2. The Medicines Control Agency is an executive agency of the Department of Health. The MCA, with expert advice from the CSM, is responsible for safeguarding public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy.

3. Further information is available at www.mca.gov.uk and www.doh.gov.uk

ENDS