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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)

PFE 25.44

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To: Anthony Wong who wrote (775)	9/11/1998 6:37:00 PM
From: Anthony Wong	Read Replies (1) of 1722

BBC: Viagra set for European lift-off Friday, September 11, 1998 Published at 17:12 GMT 18:12 UK Viagra could go on sale in Europe in about two weeks' time The top-selling anti-impotence drug Viagra looks certain to get the go-ahead for immediate sale in the UK and the rest of the European Union as soon as next week. Final clearance for the drug requires the signature of the EU's Industrial Affairs Commissioner, Martin Bangemann. But officials in Brussels have signalled that the Commissioner's approval is a mere formality. The EU's body of pharmaceutical experts - the EMEA - cleared the way in August when they voted to approve a European marketing licence for the revolutionary drug. Best-selling drug Viagra has become the fastest-selling new medicine since its launch in the US in April. But Viagra's planned launch in Europe was overshadowed last month when the US Food and Drug Administration released statistics revealing that there had been over 100 unconfirmed deaths associated to Viagra use. Of the 123 deaths the FDA identified, 69 were confirmed to have taken place in the US. Most of the US deaths were linked to heart attacks and related medical conditions, the FDA said. Almost three-quarters of the 69 Americans who died had one or more risk factors for cardiovascular disease, which contraindicate the use of Viagra. Warnings Mr Bangemann's rubber stamp next Tuesday will enable Viagra's manufacturers, Pfizer, to prepare patient information labelling in line with EU requirements. These include clear warnings about possible effects from taking the prescription-only drug. The EU's Standing Committee for Proprietary Medicinal Products (CPMP) has recommended that Viagra should not be sold to women or to males under 18 years of age. The packaging should warn against its use by the elderly and those with heart problems or low blood pressure. It should also caution against taking other medicines containing nitrates at the same time. Viagra users are also likely to be told that if one pill does not have the expected effect, taking more will not help - only the potentially painful side-effects will be enhanced. The EU committee has added an extra proviso - Viagra users who find the pill's sex-enhancing properties last more than four hours should consult a doctor. Two-week countdown After next Tuesday's expected Commission backing, it could take Pfizer two weeks to prepare the pills' labelling before the drug is available in Europe. "Approval on Tuesday requires just the signature of Mr Bangemann, then Viagra will be licensed for immediate sale on prescription subject to the restrictions set by the pharmaceutical committee," said the Commissioner's spokesman. He added: "We are stipulating that Viagra can be marketed in the EU member states but it is not up to us to decide how it is paid for - by individuals, by national health services or whatever. "That is for each member state to decide." In the UK, Viagra will cost about half as much as some doctors feared. Viagra's manufacturer Pfizer said it planned to charge the National Health Service œ4.84 per tablet, less than half the œ10 figure widely quoted in the press. news.bbc.co.uk

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