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

To: S. HYDER who wrote (3015)	5/28/1998 10:38:00 PM
From: Lazlo Pierce	Read Replies (1) \| Respond to of 9523

Pfizer standing behind Viagra labelling Thursday May 28, 9:38 pm Eastern Time By Amy Yuhn NEW YORK, May 28 (Reuters) - Pfizer Inc's statement that it would stand behind the labelling on its impotence pill Viagra despite six deaths in men using the drug reaffirms the adequate steps the company took to warn of potential side effects, one analyst said on Thursday. But another analyst said the decision on labelling ultimately lies with the U.S. Food and Drug Administration, which could order stricter cautions than the one the agency initially approved for the drug. Pfizer said late Thursday that it had reviewed the six deaths and had discussed the cases with the FDA and determined no changes to the labelling were needed. Pfizer said in a statement that ''it appears that these cases were attributed to either cardiovascular events associated with sexual activity in older men or a combination of Viagra and nitrates, which is contraindicated in the FDA-approved label.'' Viagra, or sildenafil citrate, has been on the market since April. Pfizer said more than one million prescriptions have been written. Neil Sweig, an analyst with Southeast Research Partners in New York, said more adverse reactions to drugs often are found once they are available to the general public. Ultimately, what is learned from widespread use could lead to more serious labelling, he said. ''It's good to hear that Pfizer quickly made a statement and a decision, but the bottom line is it will be the FDA that makes this decision with or without the agreement of the manufacturer,'' Sweig said. But David Saks, an analyst with Gruntal & Co in New York, said Pfizer was reacting responsibly with its quick backing of its initial labelling. ''Not changing the label is validating that the drug is safe,'' Saks said. ''They probably, in their research, found no extra concerns than what is adequately conditioned on the label.'' Pfizer, in its statement Thursday, repeated that patients taking nitrates in any form, including nitroglycerin and long-acting nitrates commonly used for chest pain, should not take Viagra. Large and sudden drops in blood pressure can occur with the co-administration of these two drugs, Pfizer said.