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Intravenous immune globulin and thromboembolic adverse events: A systematic review and meta‐analysis of RCTs
Author(s) -
Ammann Eric M.,
Haskins Cole B.,
Fillman Kelsey M.,
Ritter Rebecca L.,
Gu Xiaomei,
Winiecki Scott K.,
Carnahan Ryan M.,
Torner James C.,
Fireman Bruce H.,
Jones Michael P.,
Chrischilles Elizabeth A.
Publication year - 2016
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.24358
Subject(s) - medicine , meta analysis , adverse effect , randomized controlled trial , medline , globulin , intensive care medicine , biology , biochemistry
Prior case reports and observational studies indicate that intravenous immune globulin (IVIg) products may cause thromboembolic events (TEEs), leading the FDA to require a boxed warning in 2013. The effect of IVIg treatment on the risk of serious TEEs (acute myocardial infarction, ischemic stroke, or venous thromboembolism) was assessed using adverse event data reported in randomized controlled trials (RCTs) of IVIg. RCTs of IVIg in adult patients from 1995 to 2015 were identified from Pubmed, Embase, ClinicalTrials.Gov , and two large prior reviews of IVIg's therapeutic applications. Trials at high risk of detection or reporting bias for serious adverse events were excluded. 31 RCTs with a total of 4,129 participants (2,318 IVIg‐treated, 1,811 control) were eligible for quantitative synthesis. No evidence was found of increased TEE risk among IVIg‐treated patients compared with control patients (odds ratio = 1.10, 95% CI: 0.44, 2.88; risk difference = 0.0%, 95% CI: −0.7%, 0.7%, I 2 = 0%). No significant increase in risk was found when arterial and venous TEEs were analyzed as separate endpoints. Trial publications provided little specific information concerning the methods used to ascertain potential adverse events. Care should be taken in extrapolating the results to patients with higher baseline risks of TEE. Am. J. Hematol. 91:594–605, 2016. © 2016 Wiley Periodicals, Inc.