Fake prostate drug found in UK supply chain

Published on Saturday 2 June 2007 01:02

DRUGS watchdogs launched a criminal investigation yesterday after the discovery of fake medicine destined for prostate cancer patients in the UK.

A counterfeit batch of Casodex, a hormone treatment for men with advanced prostate cancer, was recalled by the Medicines and Healthcare products Regulatory Agency (MHRA).

The agency was alerted by a drugs wholesaler who had been offered a suspicious batch of tablets.

Checks are being carried out to see if they contain any harmful ingredients.

Initial laboratory tests on the seized samples showed they contained about 75 per cent of the quantity of active ingredient on the label. Patients were urged to contact their pharmacist as soon as possible if they are taking Casodex with the batch number 65520 printed on the medicine packages.

The MHRA said: "We take this very seriously and a criminal investigation is being carried out."

It is also investigating whether the latest discovery is linked to alerts over counterfeit batches of the antipsychotic drug Zyprexa and Plavix, a blood-thinning product.

In January the MHRA said that patients were being put at risk as counterfeiters target the NHS supply chain with fake drugs.

The agency warned it was investigating twice as many counterfeit cases as it was five years ago.

It added that with the latest discovery there was no evidence of patients having any adverse reactions specifically related to the counterfeits.

But it added: "Patients should consult their GP if they have any treatment or health concerns."

Casodex, made by AstraZeneca, works by blocking the action of the male hormone testosterone in fuelling prostate cancer.

Yesterday, the company said: "Astra- Zeneca's manufacturing and supply chain processes are monitored on a continuous basis.

"On this occasion AstraZeneca has been the target of the illegal practice of counterfeiting and, as a result, counterfeit Casodex 50mg has been introduced illegally into the UK supply chain."

The company said any patients with drugs from the affected batch should contact their pharmacist to return them and get replacements.

Dr Chris Hiley, head of policy and research at The Prostate Cancer Charity, said counterfeit Casodex had been available over the internet.

"However, this is the first time we have heard of counterfeit supplies of a well-known prostate cancer treatment arriving and, possibly, being dispensed in the UK through the 'legitimate' supply chain," she said.

"This is clearly of great concern. The wholesaler who alerted the MHRA should be commended."

Dr Hiley urged men with any concerns to contact their doctor.

"We can only reiterate the MHRA's advice that not only might the counterfeit medicine contain harmful ingredients but that the dose they have been taking may not have been effective as it is only 75 per cent of what it should have been," she said.