Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (746)	9/6/1998 9:41:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

The Age, Australia: Row over Viagra package warning September 4, 1998 By MARY-ANNE TOY Approval of the anti-impotence drug Viagra has been delayed because the manufacturer has rejected a condition that its Australian packaging carry a warning about its being associated with sudden deaths. The federal Health Minister, Dr Michael Wooldridge, announced last week that the approval had been fast-tracked on the condition it carry a boxed warning reading: ''The use of Viagra in men with cardiac disease has been associated with sudden death. ''The concomitant use of nitrates and Viagra is contraindicated.'' Viagra, which has been on sale in the United States since April with a warning that taking nitrate drugs at the same time as Viagra can be dangerous, has been linked with 69 verified reports of death. But there was no proof that Viagra had caused the fatalities, except where the nitrates warning had been ignored. Dr Wooldridge said Australia was insisting on the more extensive warning because of concern about wider health effects, but yesterday the manufacturer, Pfizer, said the wording of the recommended warning was unacceptable. The controversy was fuelled yesterday by an exchange of letters in the New England Journal of Medicine in which doctors have warned that the health dangers of Viagra, particularly for men with heart disease, could be more extensive. Pfizer's corporate affairs manager, Mr Alan Brindell, said heart problems were more likely to be due to the renewed sexual activity made possible by the drug, rather than the drug itself. The statement that Viagra's use by men with cardiac disease was linked with sudden death gave the wrong impression. ''It is inappropriate and not factually correct,'' he said. Mr Brindell said he now expected Viagra would be available for sale within four or five weeks after the parties agreed on the new wording. The New England Journal of Medicine letters cited anecdotal evidence linking Viagra with a wide range of problems including a fatal lung bleeding, heart attacks and increased bladder infections in spouses of men taking Viagra. Cardiologists said yesterday they were more concerned about problems arising from people using Viagra bought on the black market without medical supervision. The director of the Alfred's Heart Centre, Professor Garry Jennings, said several patients had obtained the drug from overseas and the sooner it was available legally here the better as it was essential that it was only taken under strict medical supervision. The president of the Cardiac Society of Australia and New Zealand, Dr Michael Jelinek, said the danger of a drug like Viagra was that people over-exerted themselves. ''If you give yourself the first bit of serious horizontal activity in years it ... could trigger a heart attack. theage.com.au