NovoSeven, a drug that has been approved only to treat hemophilia, is being used on patients having other health conditions, according to a research study at the Stanford University.
Hemophilia is a bleeding condition where the blood takes a long time to clot. The drug helps in clotting and brings down the risk of dangerous bleeding. But the study disclosed that it was being used more and more for other conditions, like cardiac surgeries, liver transplants, brain trauma and bleeding in the skull. This, what is termed as "off-label" prescribing, is happening in spite of a lack of evidence that it is beneficial.
The research provides "compelling data about the runaway use, uselessness and risk for this expensive treatment." Dr. Veronica Yanks, one of the researchers, warned doctors "to temper their enthusiasm and be more cautious" in using this drug.
The study first looked at how the drug was being used in US hospitals and then, the benefits and harms to patients.
Studying the records of 13,000 patients between 2000 and 2008, the researchers discovered that use of the drug for hemophilia had more than tripled. Nevertheless, by the end of the period it became clear that 97 percent of the time NovoSeven was used for something besides hemophilia.
When the Stanford researchers looked at how the use of the drug affected the patients, they consulted 64 past studies and found that patients being treated for other conditions did not have a better chance of surviving if they were given NovoSeven. In fact, it only increased the risk of developing a dangerous clot in a blood vessel.
Besides this risk, the drug is expensive at $10,000 a dose.
Although the company producing the drug, Novo Nordisk, has stated that it "does not promote the off-label use of NovoSeven(r) RT, and proactively worked with the FDA to update our label to address safety concerns when used outside of approved indications," doctors have felt the need for the drug in worst case scenarios. And the reasoning has been as Dr. Jerrold Levy says, "A lot of times when this is used it's used after everything else fails. You're already in a bad situation."
Nevertheless, it has been noted that while giving a physician the autonomy to choose medications is appealing, the danger exists that it could result in unhelpful, dangerous, and costly decisions.