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


To: Anthony Wong who wrote (7763)5/28/1999 4:15:00 PM
From: Anthony Wong  Respond to of 9523
 
Monsanto Strengthens Precaution on Celebrex Use With Warfarin

Bloomberg News
May 28, 1999, 3:03 p.m. ET

Monsanto Strengthens Precaution on Celebrex Use With Warfarin

Washington, May 28 (Bloomberg) -- Monsanto Co. strengthened
a precaution on the label of its Celebrex painkiller to reflect a
potentially dangerous interaction with the blood-thinning drug
warfarin, the company said in a letter to physicians.

The new label, which carries a suggestion similar to the
warning on rival Merck & Co.'s recently approved Vioxx, advises
doctors to carefully monitor patients taking the painkiller with
warfarin to make sure the two drugs don't impair blood clotting.

The problems with patients taking warfarin and Celebrex
didn't show up in clinical trials for the drug, though a number
of anecdotal reports since the drug's release in January pointed
to a potential problem, the letter said. The interaction between
Vioxx and warfarin appeared in clinical trials and when Merck
begins marketing of the drug next month, the label will cite data
on clotting time from those studies.

U.S. Food and Drug Administration spokeswoman Susan Cruzan
said the agency had received about 30 reports of potential
problems. None of the interactions have been fatal, she said, and
the additional warning shouldn't be a cause for concern for most
patients.

Monsanto spokeswoman Sally Benjamin Young said the change in
the label was intended to raise physician awareness.

''The whole point is to let physicians known they've got to
carefully monitor patients,'' she said. ''They don't need to stop
prescribing Celebrex.''

Celebrex, co-marketed with Pfizer Inc., which analyst expect
to have annual sales of more than $2 billion, was the first
therapy in the class of painkillers known as Cox-2 inhibitors.
Vioxx, the second Cox-2 drug, was approved by the FDA a week ago.

Monsanto shares fell 9/16 to 42 3/16. Merck rose 1 13/16 to
67 13/16.