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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: Dan Spillane who wrote (1332)	2/23/1999 9:08:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

Dan, concerning the labeling, which a lot of analysts are concerned with, and making a big deal of the possibility of Vioxx getting a better labeling: MedicineNet: More specifically, in regard to the labeling of Celebrex in the Physicians' Desk Reference, the risks of gastrointestinal bleeding have been reported in the lay press as an issue. Can you address that concern? Dr. Isakson: The part of the label you're referring to, which is the standard gastrointestinal warning carried by all NSAIDs, refers to a rate of 2-4% serious gastrointestinal events per year for people taking NSAIDs. In fact, the data we collected during a very careful analysis during a large clinical trial experience, suggested that the rate of occurrence of these events was very low in patients taking Celebrex, on the order of 2 in 5000 patients, for a rate of 0.04%. The strength of our data allowed us to get the F.D.A. to agree to put this information in as a qualifier to the standard gastrointestinal warning. We think this qualifier is an important distinction from all of the other NSAIDs that are currently available. So I wouldn't look at it as a concern. In fact, it is quite a distinction to have any change in the label, especially with regard to that warning.