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.