. Author manuscript; available in PMC: 2014 Mar 9.

Published in final edited form as: Semin Thromb Hemost. 2012 Oct 21;38(8):905–907. doi: 10.1055/s-0032-1328890

Table 1.

Estimates of adverse event reporting rates to the FDA

Event	Agent	Source	Events^a	Reported	Rate (%)
Hospitalization	Warfarin	Budnitz et al	33,171	381	1.15
Hospitalization	Antiplatelet agents	Budnitz et al	13,263	130	0.98
Hemorrhage	Warfarin	Connolly et al	67,200	685	1.02
VTE	Thalidomide	Bennett et al	48,000	1,118	2.33

Abbreviations: FDA, U.S. Food and Drug Administration; VTE, venous thromboembolism.

Annual estimates except VTE, which is 1998–2006 inclusive.