Novo Nordisk pays fine for off-label promotion of hemostasis drug

June 14, 2011

The battle against illegal drug promotion continues. The latest culprit is Novo Nordisk, which agreed to pay $25 million to settle civil liabilities over off-label promotion for its hemostasis drug NovoSeven (recombinant factor VIIa ) on June 10.

The battle against illegal drug promotion continues. The latest culprit is Novo Nordisk, which agreed to pay $25 million to settle civil liabilities over off-label promotion for its hemostasis drug NovoSeven (recombinant factor VIIa ) on June 10. The company also agreed to a wide-ranging corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services.

NovoSeven was approved for bleeding disorders related to hemophilia but was widely promoted as a coagulatory agent for trauma services, general surgery, cardiac surgery, liver surgery, liver transplants, and intra-cerebral hemorrhage. A meta-analysis prepared by Stanford Medical School researchers led by Veronica Yank, MD, found no evidence that NovoSven reduces mortality in surgical or trauma patients and strong evidence that it leads to increased rates of thromboembolism.

The settlement resolves a whistleblower lawsuit that is pending in federal court in Maryland. The whistleblowers stand to collect more than $3.5 million of the $25 million settlement.

Full details on the dangers of off-label use of NovoSeven will be disclosed in Drug Topics June edition.