Thrombotic Events Associated with C1 Esterase Inhibitor Products in Patients with Hereditary Angioedema: Investigation from the United States Food and Drug Administration Adverse Event Reporting System Database

Abstract

The extracted cases from the AERS indicate continuing reports of thrombotic events associated with the use of one C1 esterase inhibitor product among patients with hereditary angioedema. The AERS is incapable of establishing a causal link and detecting the true frequency of an adverse event associated with a drug; however, potential signals of C1 esterase inhibitor product-associated thrombotic events among patients with hereditary angioedema were identified in the extracted combination cases.