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MHRA recalls Plavix after counterfeit versions found

The Medicines and Healthcare Products Regulatory Authority  has announced a Class 1 recall of Plavix after counterfeits were found in the UK supply chain

The Medicines and Healthcare Products Regulatory Authority (MHRA) has announced a Class 1 recall of Plavix (clopidogrel), sanofi-aventis (S-A) and Bristol Myers Squibbís (BMS) anti-thrombosis drug, after counterfeits were found in the UK supply chain.

The counterfeits were smuggled into the UK as parallel imports from France. In conjunction with the European Medicines Authority (EMEA), the MHRA is recalling any parallel distributed stock of lots 3098 and 6Y098 of Plavix, following the ìdiscovery of counterfeits in the legitimate supply chainî.

According to the MHRA, counterfeit products may be present in the UK supply chain alongside genuine products, and stock presenting a possible risk to patients as French livery cartons with an over-label applied by a parallel distributor, or may even have been re-cartoned into an English carton by the parallel distribution repacking process. The counterfeit lots could be present alongside the genuine product.

The above lots are genuine S-A and Bristol-Myers Squibb lot numbers for which the original unchanged lots were supplied to France in French livery.

The EMEA is believed to have allowed over 30 parallel distributors to supply Plavix.

The news follows the discovery of fakes versions of GlaxoSmithKlineís (GSK) anti-psychotic drug Zyprexa (olanzapine) found in the UK supply chain and highlights the growing problem of counterfeits in the UK supply chain. Zyprexa was also supplied through French livery cartons through a parallel import and has already reached patients.

David Pruce, director of practice and quality improvement at the Royal Pharmaceutical Society of Great Britain (RPSGB), said in a statement: ìCounterfeiting in the UK is a rare occurrence but nevertheless a world-wide problem. The society has been working with the MHRA through our team of inspectors and we ask pharmacists to co-operate with the MHRAís investigation and to be alert for counterfeit medicines.î

Pfizer commented earlier this month that it was very concerned about the surges in counterfeit medicines, putting at risk the lives and well-being of patients in Europe and elsewhere.

It was due to the threat of counterfeits in the UK supply chain that Pfizer said it changed to a single supplier, Alliance Unichem in March 2007.

At the first European Parliamentary symposium on pharmaceuticals Putting an End to Drug Counterfeiting, Pfizer said: ìOur particular concern in Europe is the entry of counterfeit medicines into the legitimate supply chain via medicines trading commonly referred to as the parallel trade of medicines between member states. For this to happen, the complex and fragmented nature of medicine distribution in Europe presents multiple opportunities. Over 140m medicine packs are parallel traded across Europe each year, all are opened and altered and can travel through as many as 20-30 pairs of hands before finally reaching the patient.î

However, the European Association of Euro-Pharmaceutical Companies (EAEPC) responded by saying that there was no evidence linking parallel trade with counterfeit medicines, despite claims to the contrary.

Heinz Kobelt, secretary general of the EAEPC, told PMLive: ìIt is hard to speculate if these incidences will change the way parallel imports are regulated. There is not enough clarity on the situation, such as where they originated from or travelled to at the moment.î

ìEAEPC is taking issues seriously and in touch with the regulator to clarify the situation and get all the elements on table and make a judgement. [These occurrences] do not change the fact that parallel trade has been known for being safe ñ want to maintain safety profile of supply chain,î stated Kobelt.

ìIt is crucial to establish why this has happened and if it was not enough vigilance on the part of one party but I am convinced it has nothing to do with a systematic issue. It is very unfortunate and regrettable,î Kobelt concluded.

30th May 2007

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