Off-label use of NovoSeven has previously raised concerns, partly because a drug that promotes formation of clots can increase risk of heart attacks and strokes.
Case in point: two new reports looking at off-label use of the hemophilia drug NovoSeven and two soon-to-be-released studies comparing the off-label use of Avastin vs.
While the authors stress that there were limitations to their findings, they raise concerns that the off-label use of NovoSeven is both ineffective and less safe.
In an editorial accompanying the studies, Jerry Avorn and Aaron Kesselheim of Harvard Medical School and Brigham and Women's Hospital, Boston, questioned whether "improper" marketing may have contributed to the off-label use of NovoSeven.
Jean Slutsky, director of the agency's Center for Outcomes and Effectiveness, said the research was undertaken because clinicians have indicated that uncertainly over the risks and benefits of NovoSeven for the off-label uses posed a dilemma on whether or how to use the drug.