Self-controlled assessment of thromboembolic event (TEE) risk following intravenous immune globulin (IGIV) in the U.S. (2006-2012).

Autor: Ammann EM; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA.; Johnson & Johnson, Titusville, NJ, USA., Chrischilles EA; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA. e-chrischilles@uiowa.edu., Carnahan RM; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA., Fireman B; Kaiser Permanente Northern California, Oakland, CA, USA., Fuller CC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA., Schweizer ML; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA., Garcia C; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA., Pimentel M; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA., Leonard CE; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Baker MA; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA., Cuker A; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Leira EC; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA.; Division of Cerebrovascular Diseases, Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, IA, USA., Robinson JG; College of Public Health, University of Iowa, 145 North Riverside Drive, CPHB S441A, Iowa City, IA, 52242, USA., Winiecki SK; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.; Center for Drug Evaluation and Research at FDA, Silver Spring, USA.
Jazyk: angličtina
Zdroj: Journal of thrombosis and thrombolysis [J Thromb Thrombolysis] 2022 Feb; Vol. 53 (2), pp. 264-272. Date of Electronic Publication: 2021 Nov 24.
DOI: 10.1007/s11239-021-02610-4
Abstrakt: Since 2013, the U.S. Food and Drug administration (FDA) has required that intravenous immune globulin (IGIV) products carry a boxed warning concerning the risk of thromboembolic events (TEEs). This study assessed the incidence of TEEs attributable to IGIV in a large population-based cohort. A self-controlled risk interval design was used to quantify the transient increase in TEE risk during the risk interval (days 0-2 and 0-13 following IGIV for arterial and venous TEEs, respectively) relative to a later control interval (days 14-27 following IGIV). Potential IGIV-exposed TEE cases from 2006 to 2012 were identified from the FDA-sponsored Sentinel Distributed Database and confirmed through medical record review. Inpatient IGIV exposures were not included in the venous TEE analysis due to concerns about time-varying confounding. 19,069 new users of IGIV who received 93,555 treatment episodes were included. Charts were retrieved for 62% and 70% of potential venous and arterial cases, respectively. There was a transient increase in the risk of arterial TEEs during days 0-2 following IGIV treatment (RR = 4.69; 95% CI 1.87, 11.90; absolute increase in risk = 8.86 events per 10,000 patients, 95% CI 3.25, 14.6), but no significant increase in venous TEE risk during days 0-13 following outpatient IGIV treatments (RR = 1.07, 95% CI 0.34, 3.48). Our results suggest there is a small increase in the absolute risk of arterial TEEs following IGIV. However, lower-than-expected chart retrieval rates and the possibility of time-varying confounding mean that our results should be interpreted cautiously. Continued pharmacovigilance efforts are warranted.
(© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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