By Flemming Emil Hansen
COPENHAGEN -(Dow Jones)- The off-label use of Danish pharmaceutical firm Novo Nordisk A/S's (NOVO-B.KO) hemophilia drug NovoSeven in U.S. hospitals has exploded in recent years, the effects are undocumented, and in some cases the use adds risks of thrombotic incidents, warns two new studies published in the Annals of Internal Medicine late Monday.
According to the studies, which comprise 12,644 patient records from U.S. hospitals and reviewed the benefits and harms of the drug, NovoSeven, or rFVIIa, a so-called recombinant procoagulant, has no proven effect on the mortality rate of patients when used for off-label purposes.
Novo Nordisk said Monday it urges caution of off-label use of NovoSeven and has never promoted such use.
"It will never be our responsibility to control and regulate the off-label use. What we can do is never to promote it, which we have never done," Novo Nordisk executive vice president and chief science officer, Mads Krogsgaard Thomsen, told Dow Jones Newswires.
While off-label use of drugs isn't illegal according to U.S. law, the promotion of such use by the manufacturer is.
NovoSeven hasn't been approved by the U.S. Food and Drug Administration for use other than the treatment of hemophilia. The drug targets a narrow group of some 5,000 hemophilia patients worldwide who have developed inhibitors to other procoagulants.
The drug has won popularity in U.S. hospitals as part of the treatment of a number of other conditions, including body and brain trauma, intracranial hemorrhage, aortic aneurysm, and in connection with cardiovascular surgery, neurosurgery and cancer and stem cell transplants. From 2000 to 2008, the off-label use of rFVIIa in U.S. hospitals increased more than 140-fold, and in 2008 97% of all uses were off-label, according to one study.
"Off-label use of rFVIIa in the hospital setting far exceeds use for approved indications. These patterns raise concern about the application of rFVIIa to conditions for which strong supporting evidence is lacking," one study said.
The studies, which have mainly been funded by the Agency for Healthcare Research and Quality, examined the in-hospital use of rFVIIa for five off-label indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation and prostatectomy. The studies found that no available evidence suggested a reduction in the mortality rate in patients by use of rFVIIa, and using the drug for cardiac surgery and intracranial hemorrhage increased the risk for thromboembolism.
"Our label completely reflects the findings of this study," Krogsgaard Thomsen said.
"I can't object to the study, since it is fully in line with what we ourselves have communicated," he said, adding the in-hospital use of NovoSeven makes up 15% of the total use, with the treatment of hemophilia outside of hospitals accounting for the remaining 85%.
"The doctors use NovoSeven as a last resort medicine in patients that may otherwise be doomed. Our view is, that we neither support nor do we stand by the off-label use," Krogsgaard Thomsen said.
"On the other hand," he said, "I can't object to a physician who makes the judgment to use it as a last resort. But it can't be the responsibility of the company. The physicians that use NovoSeven out of label must do it at their own conscience."
Copyright © 2011 Dow Jones Newswires
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