If one read my paper [1] 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 [2] 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.


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