* Doctors give NovoSeven to stop other serious bleeding
* 35 studies weighed in new analysis
* Danger most pronounced in older patients
By Gene Emery
BOSTON (Reuters) - Using high doses of Novo
Nordisk's anti-clotting medicine to treat dangerous bleeding in
non-hemophiliacs may raise the risk of heart attack or related
complications, researchers said Wednesday.
The drug, NovoSeven, is a genetically engineered version of
factor VII, a key protein missing in some people with the
bleeding disease hemophilia.
Some doctors prescribe the drug in "off-label" use to stop
unwanted bleeding associated with stroke, trauma, surgery,
transplantation and other medical conditions. Doctors may
prescribe any approved drug for any reason they want to.
But this drug may not be worth the risk, said Dr. Marcel
Levi of the University of Amsterdam and colleagues at Novo
Their analysis of 35 studies found that the overall
likelihood that an artery would clog was 68 percent higher with
NovoSeven therapy compared to a placebo.
The risk of heart attack, angina or related complication
more than doubled, the researchers reported in the New England
Journal of Medicine .
People over 65 who got the drug were more than twice as
likely to develop an unwanted clot in an artery than younger
patients, they found. Those over 74 were three times more
"This is a highly effective drug in patients with excessive
blood loss in various circumstances. But the main message is
you need to realize that there is a price to be paid," Levi
said in a telephone interview.
"If a patient's bleeding so serious he or she may have a
major problem or even die, you can accept the small increased
risk of having an arterial thrombosis (clot)," Levi said.
"On the other hand, if it's not excessive bleeding and
there are other options to explore, the safety issue may hold
you back from doing this."
The treatment did not increase the risk of unwanted clots
in veins, regardless of age, the researchers found. It
increased the risk of stroke, but not enough to be
Dr. Louis Aledort of the Mount Sinai School of Medicine in
New York said in a commentary that 4 percent of the NovoSeven
used at his hospital is for non-approved therapy. "At other
centers, the rate of off-label use may be even higher," Aledort
Levi said hospitals that are quick to give the drug may now
want to reconsider that practice.
(Editing by Philip Barbara)
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