Inquiry on hormone drug

The Health Division's Medicines Regulatory Unit is investigating the importation of a hormone drug after a British newspaper reported it was being "withdrawn over fears of mad cow disease".

The Independent of London reported that Metrodin High Purity (HP), imported from Italy, was being withdrawn from British fertility clinics because of "the remote possibility that it may be infected with the human form of BSE".

It said that the UK's Committee on Safety of Medicines put out a safety warning advising clinics to stop using this drug, made by Serono Pharmaceuticals Ltd. in Italy.

This advice was issued solely as a precaution after a case of variant Creutzfeldt Jakob's disease (vCJD) was confirmed in Italy. The drug is made from human urine sourced in Italy and research found that the prions believed to carry vCJD infectivity can appear in urine.

MRU director Lilian Wismayer said they were looking into the problem since Metrodin High Purity is imported into Malta. However, Malta's batch is imported from Switzerland, not Italy.

"We are looking into this problem and we are aware that the UK's Committee on Safety of Medicines has advised the withdrawal of this product purely as a precautionary measure... It is stressed that there have been no reported cases of the transmission of CJD via urine or products derived from urine'," Ms Wismayer said.

"We are currently in contact with the local agent and the qualified person concerned who is responsible to monitor any safety issues or potential adverse effects," she said.

Metrodin High Purity is used by women in Malta as a form of fertility treatment.

This drug is chiefly used to stimulate egg development in the ovaries of women having in vitro fertilisation because it contains the follicle stimulating hormone, urofollitrophin.

It is given to women who have a hormone deficiency leading to failure to ovulate, and more rarely to men whose sperm production is affected by a hormone problem.

Dennis Attard Bondi, medical rep of Kerubino, which imports the drug into Malta, said when contacted there was no cause for alarm.

"We have contacted our Swiss partners and we were assured that no other countries across the globe had halted importation of this drug. There are different batches which are distributed in different countries," he said.

"We import the batches from Switzerland. Apart from that, the UK decided to stop its importation from Italy only as a precautionary measure," he said.

Mr Attard Bondi insisted that Maltese clients taking this drug should put there minds at rest because at this point in time there was no cause for concern.

"People should not panic or stop the treatment. They should consult their doctor before taking any action," he said.