BMS STRENGTHENS BLEEDING RISK WARNING FOR COUMADIN

Bristol-Myers Squibb has significantly strengthened its bleeding risk warning for patients on its blood-thinner Coumadin by adding a "black box" warning to the product's label, according to revised labeling posted on the FDA website.

The warning emphasized in the black box on the new label for Coumadin (warfarin sodium) warns the drug can cause "major or fatal bleeding," and says that "patients should be instructed about prevention measures to minimize risk of bleeding and to report immediately to physicians signs and symptoms of bleeding."

The boxed warning includes information that was already part of the old label, and is not based on new data or clinical studies, a BMS spokesman said.

Warfarin is sold in generic form by other companies. The drug is indicated to prevent blood clots in patients with certain types of irregular heartbeats or who have had a heart attack or heart-valve replacement surgery.

The new label can be seen at: www.fda.gov/cder/foi/label/2006/009218s102lbl.pdf (http://www.fda.gov/cder/foi/label/2006/009218s102lbl.pdf).