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More fake Lipitor detected in UK

Pfizer calls for thorough investigation into the spread of counterfeit medicines in `vulnerable' European supply chain

Pfizer has drawn attention to what it describes as the 'vulnerability' of the European pharmaceutical distribution system after UK regulators said they had discovered another batch of counterfeit packs of the firm's top-selling cholesterol-lowering drug, Lipitor (atorvastatin).

The world's largest pharmaceutical firm is now recalling two batches of 20mg Lipitor, each of which contains 120,000 packets, from the UK supply chain.

The Medicines and Healthcare products Regulatory Agency (MHRA) first detected fake Lipitor tablets in July 2005 and revealed on July 19 this year that more packs from that batch had appeared. The latest batch bears a different lot number.

'This is the third time that a Pfizer medicine has been targeted after the two previous incidents related to the discovery of the same batch of counterfeit Lipitor 20mg in the last year,' said Pfizer UK managing director, Olivier Brandicourt. 'Enough is enough, and we are calling for the MHRA and law enforcement agencies to conduct a full and thorough investigation into this incident and the general vulnerability of the medicines supply chain.'

The MHRA said that while tests had indicated that there was no immediate risk to patients, it could not guarantee the quality of the counterfeit products.

'The MHRA advises patients to stop taking tablets from this batch and to contact their pharmacist,' said MHRA head of enforcement, Danny Lee-Frost. 'If patients have any concerns about possible side effects they should discuss them with their doctor.'

Any patient who has the Lipitor 20mg product with lot number 067404K3 or 004405K1 anywhere on the pack has been advised to stop taking the tablets and contact their pharmacist to receive new supplies of the drug. Patients have also been told to wait 24 hours before taking the first tablet of a new supply.

Pfizer said that it has recently introduced a number of policies to protect its medicines from counterfeiting, such as the phased introduction of tamper evident packaging.

The incident highlights the rising threat that counterfeit medicines pose. Pfizer said that much of the European pharmaceutical distribution system was being increasingly targeted by criminal gangs.

Lipitor currently has annual global sales of around $12bn, and is therefore seen as a prime target for counterfeiters.

30th September 2008

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