Blood Thinner Coumadin Gets Black Box Warning Over Fatal Bleeding Side Effect
Jessica Fraser, Oct 9, 2006
NewsTarget
U.S. health officials announced on Friday that drug maker Bristol-Myers Squibb has added a
black box warning to its blood-thinning drug Coumadin warning of possible "major or fatal
bleeding." 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.
Jessica Fraser, Oct 9, 2006
NewsTarget
U.S. health officials announced on Friday that drug maker Bristol-Myers Squibb has added a
black box warning to its blood-thinning drug Coumadin warning of possible "major or fatal
bleeding." 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.
Blood Thinner Coumadin gets the Black Box
Warning over Fatal Bleeding
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