According to the U.S. Food and Drug Administration, Coumadin -- known generically as warfarin -- will carry the agency's most serious "black box" warning on the potentially fatal bleeding risk. Coumadin had previously warned of a "risk of hemorrhage," but that warning was not highlighted in a black box.
Warfarin is a widely used anticoagulant, meant to thin the blood to prevent clots from forming or growing larger. Such medications are thought to help reduce the risk of stroke and heart attack caused by clots in the arteries.
The black box warning appearing on Bristol-Myers' Coumadin packaging also warns that serious or fatal bleeding is more likely to occur early on when patients start using the drug or when they begin higher doses. The warning cautions patients that they may be more susceptible to the risk if they are 65 and older, or if they have a history of gastrointestinal bleeding, hypertension or heart disease.
Bristol-Myers Squibb spokesman Ken Dominski verified the addition of the black box warning, and said the change applied to both the tablet and injectable forms of the drug. Dominski also said Bristol-Myers had worked with the FDA to make the change, but did not elaborate on whether or not the agency had required the new warnings.
Consumer advocate Mike Adams, author of "Take Back Your Health Power," said the warning is not surprising, since "Coumadin is actually the same chemical used as rat poison by pest exterminators."
Coumadin works to kill patients in exactly the same way it kills rats: "by causing them to bleed to death from the inside," Adams said.
Pharmaceutical industry critics say drugs like Coumadin are largely unnecessary, since much safer natural alternatives can also effectively thin the blood to prevent dangerous clots. For example, fish oil supplements and oily fish rich in omega-3 fatty acids both act as natural blood thinners.