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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
Author(s) -
Gandhi Pranav K.,
Gentry William M.,
Bottorff Michael B.
Publication year - 2012
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/j.1875-9114.2012.01126
Subject(s) - adverse event reporting system , hereditary angioedema , medicine , adverse effect , angioedema , database , confidence interval , food and drug administration , pharmacology , computer science , immunology
Study Objective To investigate reports of thrombotic events associated with the use of C1 esterase inhibitor products in patients with hereditary angioedema in the United States. Design Retrospective data mining analysis. Source The United States Food and Drug Administration ( FDA ) adverse event reporting system ( AERS ) database. Measurements and Main Results Case reports of C1 esterase inhibitor products, thrombotic events, and C1 esterase inhibitor product–associated thrombotic events (i.e., combination cases) were extracted from the AERS database, using the time frames of each respective product's FDA approval date through the second quarter of 2011. Bayesian statistical methodology within the neural network architecture was implemented to identify potential signals of a drug‐associated adverse event. A potential signal is generated when the lower limit of the 95% 2‐sided confidence interval of the information component, denoted by IC 025 , is greater than zero. This suggests that the particular drug‐associated adverse event was reported to the database more often than statistically expected from reports available in the database. Ten combination cases of thrombotic events associated with the use of one C1 esterase inhibitor product (Cinryze) were identified in patients with hereditary angioedema. A potential signal demonstrated by an IC 025 value greater than zero ( IC 025 = 2.91) was generated for these combination cases. Conclusion 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.