high doses of Novo Nordisk's anti-clotting medicine to treat dangerous bleeding
in non-haemophiliacs may raise the risk of heart attack or related complications,
researchers said. The drug, NovoSeven, is a genetically engineered version
of factor VII, a key protein missing in some people with the bleeding disease
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 Nordisk.
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.
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 likely.
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.
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.
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."
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 statistically significant.
Aledort of the Mount Sinai School of Medicine in New York said in a commentary
that 4% of the NovoSeven used at his hospital is for non-approved therapy.
"At other centres, the rate of off-label use may be even higher,"
said hospitals that are quick to give the drug may now want to reconsider