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.
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