Comparative thrombotic event incidence after infusion of recombinant factor VIIa vs. factor VIII inhibitor bypass activity—reply to a rebuttal
Article first published online: 4 APR 2005
Journal of Thrombosis and Haemostasis
Volume 3, Issue 4, page 819, April 2005
How to Cite
ALEDORT, L. M. (2005), Comparative thrombotic event incidence after infusion of recombinant factor VIIa vs. factor VIII inhibitor bypass activity—reply to a rebuttal. Journal of Thrombosis and Haemostasis, 3: 819. doi: 10.1111/j.1538-7836.2005.01214.x
- Issue published online: 4 APR 2005
- Article first published online: 4 APR 2005
If one read my paper  carefully, it went to great pains to explain that the FDA Medline listings do not reveal the underlying diagnosis of any patient receiving the biological, just the adverse event (AE) and type of thrombosis. Therefore, in the Discussion it was clear that one could not possibly know for each product on- vs. off-label use. Only the Medwatch report itself can accomplish what is being requested here.
Makris and van Veen  assume inaccurately that most rVIIa events occurred in non-hemophilic patients. Perhaps they have in their possession the original Medwatch reports, which I do not.
FEIBA has been reported to be used together with rVIIa. However, it is possible that all their reported thrombotic AEs were in hemophilic patients with inhibitors. If, in fact, all the rVIIa thrombotic events occurred in non-hemophilic patients, then one must certainly be cautious in its use in patients without any coagulation defect.