THOUSANDS of packets of an anti-cholesterol drug taken by millions of Britons as a treatment for heart disease are to be recalled after the discovery of counterfeit pills awaiting distribution to NHS patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) is contacting all pharmacies in the country after identifying fake boxes of Lipitor, a powerful statin that is the world’s bestselling drug.

Copies of the drug, which was prescribed by British doctors 11 million times last year, have been traced to two wholesalers in England and confirmed as counterfeit by laboratory tests in the past 48 hours.

The fake drugs, which were marked with a real Lipitor batch number, were found to contain another statin not currently marketed in Britain.

It is not known how many patients may have taken the counterfeit pills and what effect they may have had on their medication regimes, although it is not thought to pose a serious risk to health.

After discovering 73 fake packets, the MHRA decided to recall all that remains of a 120,000-packet batch, each containing 28 x 20mg Lipitor pills, marked 004405K1 and imported into the country in February. The alarm was raised last week after customs officers confirmed that they had intercepted fakes in the Dutch port of Rotterdam in late May.

It is only the third time in the past ten years that counterfeits have been detected in the legitimate drug supply chain in Britain, and the first discovery of a drug used to treat a condition as serious as heart disease.

Lipitor, which is worth £24 per pack of 28, brings in £12 billion annually for its manufacturer, Pfizer, the pharmaceutical group. Statins, which are prescribed to people at an increased risk of cardiovascular disease, such as diabetics and sufferers of angina and high blood pressure, are credited with preventing more than 10,000 heart attacks, strokes and major cardiac operations in Britain every year.

The recall was sent out to the country’s 20,000 chemists and wholesalers, which act as commercial middlemen between manufacturer and chemists. The rapid action by the agency is part of a new offensive against fake medication production, which is attracting a growing number of criminals and is regarded as one of the greatest threats to public health. Thousands of patients in the developing world are thought to have died as a direct result of medicine counterfeiting in recent years, with vital drugs such as anti-malaria treatments and insulin found to be fakes.

Nimo Ahmed, head of intelligence at the MHRA, said that the discovery of the drugs, which came from outside the EU, showed that counterfeit medicines could get into any supply chain.

This month Kent Woods, the agency’s chief executive, met other national drug regulators to discuss implementing a Europe-wide crackdown on counterfeiting. A taskforce has been set up, including former military personnel, police and experts on high-tech crime.

“This discovery illustrates what we have been saying for some time, that no pharmaceutical supply chain is impenetrable,” Mr Ahmed said.

“But the MHRA remains at the forefront of tackling this crime. The UK’s supply chain is one of the most difficult to penetrate because of the safeguards. We will continue to maintain such vigilance and keep improving our anti-counterfeit methods to protect our public and stay ahead of the criminals.”

Initiatives include improved inspector training, more liaison work between government and industry and increasing awareness among the public of the dangers of buying lifestyle drugs in pubs and clubs.

Last August, copies of the drugs Cialis, which is taken for erectile dysfunction, and Reductil, which helps weight loss, were the subject of alerts.

Interest in fake drugs has increased with the development of more sophisticated counterfeiting technology, and the opportunities to sell over the internet, and its vast rewards.

DRUG DEALING

Parallel trading, where medicines are bought from another EU country and sold in Britain at a profit, is thought to be responsible for breaches in the supply

Britain receives about 140 million parallel-traded medicines a year

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