PMID- 26973084
OWN - NLM
STAT- MEDLINE
DCOM- 20170623
LR  - 20230124
IS  - 1096-8652 (Electronic)
IS  - 0361-8609 (Linking)
VI  - 91
IP  - 6
DP  - 2016 Jun
TI  - Intravenous immune globulin and thromboembolic adverse events: A systematic 
      review and meta-analysis of RCTs.
PG  - 594-605
LID - 10.1002/ajh.24358 [doi]
AB  - 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. (c) 2016 Wiley 
      Periodicals, Inc.
CI  - (c) 2016 Wiley Periodicals, Inc.
FAU - Ammann, Eric M
AU  - Ammann EM
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Haskins, Cole B
AU  - Haskins CB
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Fillman, Kelsey M
AU  - Fillman KM
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Ritter, Rebecca L
AU  - Ritter RL
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Gu, Xiaomei
AU  - Gu X
AD  - Hardin Library for the Health Sciences, University of Iowa, Iowa City, Iowa.
FAU - Winiecki, Scott K
AU  - Winiecki SK
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation & 
      Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
FAU - Carnahan, Ryan M
AU  - Carnahan RM
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Torner, James C
AU  - Torner JC
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Fireman, Bruce H
AU  - Fireman BH
AD  - Division of Research, Kaiser Permanente Northern California, Oakland, California.
FAU - Jones, Michael P
AU  - Jones MP
AD  - Department of Biostatistics, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
FAU - Chrischilles, Elizabeth A
AU  - Chrischilles EA
AD  - Department of Epidemiology, College of Public Health, University of Iowa, Iowa 
      City, Iowa.
LA  - eng
GR  - R01 NS048597/NS/NINDS NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20160424
PL  - United States
TA  - Am J Hematol
JT  - American journal of hematology
JID - 7610369
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Humans
MH  - Immunoglobulins, Intravenous/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Thromboembolism/*chemically induced/etiology
EDAT- 2016/03/15 06:00
MHDA- 2017/06/24 06:00
CRDT- 2016/03/15 06:00
PHST- 2016/03/03 00:00 [received]
PHST- 2016/03/07 00:00 [accepted]
PHST- 2016/03/15 06:00 [entrez]
PHST- 2016/03/15 06:00 [pubmed]
PHST- 2017/06/24 06:00 [medline]
AID - 10.1002/ajh.24358 [doi]
PST - ppublish
SO  - Am J Hematol. 2016 Jun;91(6):594-605. doi: 10.1002/ajh.24358. Epub 2016 Apr 24.