Here's a story about the pitfalls off-label drug use. The clot-promoting drug NovoSeven, approved for patients who lack a particular clotting gene or those who can't tolerate an alternative hemophilia drug, is only used for those indications 3 percent of the time when administered in hospitals. The other 97 percent of hospital doses go to other patients--and that's proven to be dangerous, according to studies in the new Annals of Internal Medicine.
As the New York Times reports, the common practice of using NovoSeven to treat hemorrhagic strokes and prevent bleeding during heart surgery doesn't just fail to improve survival. It also introduces additional risks, namely the risk of a blood clot in the heart or brain, which in turn can trigger heart attacks or strokes. "It's scary," Brigham and Women's Hospital professor Dr. Jerry Avorn told the NYT.
Surgeons tell the NYT they like NovoSeven--made by Novo Nordisk--because it works quickly. That's been especially helpful in some trauma patients, who might have bled to death without it. One doctor called it a "miracle treatment." But recent studies have shown no overall survival benefits in trauma patients, just as this new study shows some dangers of NovoSeven in heart and stroke patients. Some doctors have cut back on their use of it, and at least one hospital has a new policy requiring surgeons to ask a hematology consultant before administering it.
"This is a powerful drug, and we don't fully understand it," Dr. Veronica Yank of Stanford, an author on both papers, told the Times. And for all off-label drug uses, anecdotal reports can be misleading, and departing from the approved use might carry unexpected risks.
And as off-label marketing settlements stack up, these caveats are important. Novo points out that NovoSeven is used most outside the hospital, for FDA-approved indications. The company also says it didn't promote NovoSeven for off-label uses and that it has worked with FDA to make sure the drug's label includes cautions about unapproved uses. As we know from those repeated marketing settlements, not every drugmaker can say the same.