Heart Pills taken
by Millions recalled as Fakes are found
July 29, 2005
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.
Source: http://www.timesonline.co.uk
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