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

To: BigKNY3 who wrote (5144)	8/24/1998 7:54:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

Pfizer's Viagra Used by 69 Who Died; FDA Says Drug Still Safe Bloomberg News August 24, 1998, 6:11 p.m. ET Pfizer's Viagra Used by 69 Who Died; FDA Says Drug Still Safe Washington, Aug. 24 (Bloomberg) -- Pfizer Inc.'s blockbuster impotence drug Viagra was taken by 69 patients in the U.S. who later died, the U.S. Food and Drug Administration said, adding its opinion of the drug's safety hasn't changed. In an update posted on its web site, the FDA said between March and July it received reports of 123 patients who died after receiving a prescription for Viagra. However, in 42 of those cases, either the information couldn't be confirmed, because it came from a rumor or other unverifiable source, or the agency couldn't be sure the patients actually took Viagra, the FDA said. Another 12 reports involved patients outside the U.S. ''This posting does not suggest a change in FDA's perspective concerning the safety of Viagra,'' the agency said on the web site. ''The intent is simply to provide easier access for those who have requested this information.'' Officials at the FDA had no further comment. Officials at New York-based Pfizer couldn't be reached. In the past, the FDA has said it hasn't found Viagra to be the direct cause of previously reported death and both the agency and the company have repeatedly said the drug is safe when used properly. The latest safety update comes after Public Citizen, a Washington-based consumer watchdog group, last week petitioned the FDA to convene an expert advisory panel to review the drug. Unlike most other new therapies, Viagra didn't pass through an FDA panel before approval. Public Citizen said the dangers of the drug aren't fully understood. Both the FDA and Pfizer said the drug is safe. Viagra has seen unprecedented demand and garnered sales of more than $400 million in its first three months on the market. Shares of New York-based Pfizer fell 11/16 to 105 3/8 earlier. The company has recently faced several lawsuits from men who claimed they suffered heart attacks after taking the drug, The 69 deaths include 39 reported July 21, the last time the FDA issued an official update. Of the 69 U.S. patients who died after taking Viagra, two had strokes, 46 suffered some kind of heart problem and 21 died from unknown or unconfirmed causes, the FDA said. While the Viagra label doesn't contain a specific warning for heart patients, it does advise doctors that sexual activity carries risks, and ''physicians may wish to consider the cardiovascular status of their patients before prescribing the drug.'' At least 66 of the patients who died were men, the agency said. The average age of the patients in 55 reports which included that information was 64, the FDA said. The ages of patients who died ranged from 29 to 87, the agency said. At least 12 of the patients took Viagra along with a heart medication that the company and the FDA have warned can have a dangerous interaction with Viagra, the agency said. Most of the 69 patients were also found to have at least one risk factor for heart disease, the FDA said. ''As with all approved medications, the FDA will continue to monitor the postmarketing safety of Viagra by carefully reviewing reports of death and other serious adverse events and will continue to evaluate the need for further regulatory action,'' the agency said. --Kristin Jensen in the Washington newsroom (202) 624-1843 with quote.bloomberg.com

To: BigKNY3 who wrote (5144)	8/24/1998 10:46:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 9523

NEWS!! BBC - Viagra set for European licence Monday, August 24, 1998 Published at 11:11 GMT 12:11 UK Viagra: should soon be available in the UK European Commission experts have recommended that the impotence drug Viagra is licensed for use across the continent. The EC's Standing Committee for Medicinal Products for Human Use has voted in favour of granting a licence following consultation of member states. It is now all but a formality that the EC will issue a licence for Viagra. The drug should available on prescription only in the UK either in September or October. The EC vote marks the end of a complex vetting procedure, instigated whenever an application is made to market a major new drug in Europe. Viagra first had to be approved by the European Agency for the Evaluation of Medicinal Products (EMEA) which scrutinised an application made by the drug's manufacturers, Pfizer. Fastest seller Viagra has become the fastest selling prescription drug since it was first launched in the US in April. Doctors estimate that as many as 10% of the male population suffers from impotence problems, and the BMA has warned that requests for the drug could add at least œ1bn to the NHS drugs bill. The drug works by relaxing the tissues surrounding the penis, allowing blood to flow more easily to the area and increasing the likelihood of an erection. Potential for abuse Doctors fear Viagra may be abused by some patients as it has been alleged it can also boost sexual performance among men who do not suffer from impotence. The drug can also heighten sexual pleasure for women. At least 40 men have died after taking the drug in the US. They ignored warnings that Viagra can be dangerous if taken in combination with drugs for heart disease. news.bbc.co.uk