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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: flickerful who wrote (5256)	8/27/1998 10:15:00 AM
From: Anthony Wong	Respond to of 9523

Viagra set for European lift-off [with Prof. Rolf Bass's comments] Thursday, August 27, 1998 Published at 12:12 GMT 13:12 UK Viagra will repackaged to include health warnings The impotence wonder drug Viagra is set to be launched in Europe in September against a backdrop of 69 American deaths associated with use of the drug. The US Food and Drug Admininstration identified a total of 123 deaths linked with the drug, of which 69 were in the US. Most of these were linked to heart attacks and related medical conditions. Of the remaining 54 fatalities, 12 were foreign deaths and 30 were unverifiable reports. Reporters said they did not know if the drug had been used in the other 12 cases. Viagra is in the final stages of approval by the European Commission. Once manufacturer Pfizer receives approval - expected to come in September - the drug will be available in all European Union member states. The European Agency for Evaluation of Medicinal Products (EMEA), the agency which co-ordinates drug approval in the European Union, has recommended to the EC that the sexual dysfunction drug be licensed. But the head of the EMEA's human medicines unit, Professor Rolf Bass, added: "We're certainly reviewing very carefully the situation developing in the US." Theories as to why the deaths in the US occurred currently point not to a direct side-effect of taking the drug itself but to a strain on the heart from the "physical exertion" of sexual activity. Speaking on Radio 4's Today programme, Professor Bass said it is difficult to give proof that this argument is true. "But it is certainly the argument put forward from the company and accepted so far by the US FDA, and by their explanation it wouldn't make any difference whether you shovel snow in the winter or cut trees," he said. Patient information on the drug has been put out in advance of its launch in Europe because of the massive public interest in Viagra, Professor Bass said. The labelling "contains information and warnings relating to the heart and sensations and so forth which are not in the American labelling", he said. Viagra for Australians Viagra is also scheduled to be launched in Australia within weeks. Australian Health Minister Michael Wooldridge predicted that sales of the drug would probably outstrip those of the century's other wonder drug, penicillin. Pfizer Australia has given the go-ahead for the Viagra to be sold in the country as soon as it can alter its packaging to include health warnings. Similar to the European labelling, the revised patient information will warn: "The use of Viagra in men with cardiac disease has been associated with sudden death. The concomitant use of nitrates and Viagra is contraindicated." 'Unprecedented demand' Mr Wooldridge said the approval process had been fast-tracked for fear of a burgeoning black market and sales of the drug over the Internet. "If overseas experience is anything to go by, there will be unprecedented demand for it," Mr Wooldridge said. The drug will be expensive to deter men from indulging beyond the prescribed dosage. "It's not a recreational drug, it's a serious medication. It's not something you take after a night out," he added. news.bbc.co.uk