Alarm raised over counterfeit Cialis
pharmafile | August 26, 2004 | News story | |Â Â Â
Patients taking Cialis have been warned that counterfeit versions of the impotence drug are in circulation in the UK, the first time in ten years that fake copies of a drug have been found in the supply chain.
The MHRA issued a warning and have recalled the two lot numbers affected after a patient complained about a crumbling tablet.
"Patients who are in possession of this counterfeit drug should return it immediately," said MHRA chief executive Kent Woods. "Whilst initial tests show that the product does not pose an immediate risk to patients, the quality of this product cannot be guaranteed. If patients think that they have taken the product and are concerned about any side-effects they should consult their doctor."
The MHRA stressed that no genuine batches manufactured by Lilly were affected by the recall, but Lilly has set up a free phone number for patients who are concerned about the incident.
Counterfeit medicines is a growing problem around the world for the industry, although the World Health Organisation which is trying to bring agreement on an international definition of 'counterfeit' admits the extent of the trade is not known.
The discovery of the fake Cialis tablets is the first discovery of counterfeits in the UK since a case involving Azantac (ranitidine) in 1994 but is nevertheless worrying for manufacturers whose revenues and reputations are at stake.
Erectile dysfunction drugs have been among the favourite targets for counterfeiters who often generate business through unregulated internet 'pharmacies'.
Pfizer, the maker of market leader Viagra launched a crackdown on the online traders in August, with US law enforcement agencies, in an effort to block sales of counterfeit and illegal 'generic' versions of the drug.
The company has also launched a new US public awareness advertising campaign and online resource on www.viagra.com to help educate consumers about how to avoid illegitimate websites, safely purchase genuine Viagra online, and help minimize Viagra spam.
Commenting on the UK counterfeits, new ABPI director general Dr Richard Barker said: "The integrity of the supply chain is of utmost importance to the pharmaceutical industry, and it is equally important that the manufacturer's original packaging is not interfered with."
Parallel trade, which is entirely legal under EU law is often linked to counterfeiting activity by the industry because of the re-packaging involved. Dr Barker said he did not consider there to be a direct link, but said they were of a "similar nature" in that they did not come through the conventional supply chain.
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