Dataset Information

Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study.

ABSTRACT:

Background

Intravenous immunoglobulin (IVIG) is a biological product with adverse effects that appears to vary considerably among different IVIG preparations.

Objectives

To describe the adverse events of patients given intravenous immunoglobulin infusions.

Method

Data was collected on all patients receiving IVIG infusion at a tertiary hospital from January 2001 to December 2010. Descriptive statistics was used.

Results

77 patients (45 males, 32 females) received IVIG infusions. Thirty two percent (n = 25) experienced adverse reactions. The most common indication was Kawasaki disease (85.7%) followed by immunodeficiency disorders (7.8%). Majority of the patients were children, with the highest frequency of infusions among those aged 2 to 8 years old (52%). 36 infusions were associated with occurrence of adverse effects. Fever was the most common adverse event (n = 11, 30.6%), followed by rash (n = 8, 22.2%) and chills (n = 7, 19.4%). Other adverse events were cyanosis (n = 3, 8.3%), hypotension (n = 2, 5.6%), hypothermia (n = 2, 5.6%), irritability (n = 1, 2.8%), vomiting (n = 1, 2.8%), and chest pain (n = 1, 2.8%). Adverse events were observed to occur most frequently within 1 to 6 h from onset of IVIG infusion. Among the various IVIG preparations available locally (Gammagard, Kiovig, Gamimune, Veno-S & IV Globulin S), Gammagard was the brand frequently used (50.7%). It also has the most number of adverse events, with 17 out of 41 (41.5%) infusions resulting in adverse reactions. Most of the reactions occurred with fast infusion rates, and clinical manifestations subsided when the rate of infusion was reduced.

Conclusion

In this study, thirty two percent of patients given IVIG infusions experienced adverse events. Fever was the most common manifestation. Symptoms occurred within 1 to 6 h from onset of infusion, were affected by fast infusion rates, and managed by reducing the rate of infusion.

SUBMITTER: Palabrica FR

PROVIDER: S-EPMC3826603 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Publications

Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study.

Palabrica Frances Rose R FR Kwong Shirley L SL Padua Florecita R FR

Asia Pacific allergy 20131031 4

<h4>Background</h4>Intravenous immunoglobulin (IVIG) is a biological product with adverse effects that appears to vary considerably among different IVIG preparations.<h4>Objectives</h4>To describe the adverse events of patients given intravenous immunoglobulin infusions.<h4>Method</h4>Data was collected on all patients receiving IVIG infusion at a tertiary hospital from January 2001 to December 2010. Descriptive statistics was used.<h4>Results</h4>77 patients (45 males, 32 females) received IVIG ...[more]

PMID: 24260730

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Project description:BackgroundSerious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized.ObjectiveThe objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered.MethodsThe Food and Drug Administration's MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex® platform from Advera Health Analytics, Inc. to identify all reports that included one or more of ten different SCAEs (package insert incidence???1%) and where an intravenous benzodiazepine, dexmedetomidine, or propofol was the primary suspected drug.ResultsAmong the 2326 Food and Drug Administration's MedWatch Adverse Event Reporting System cases reported, 394 (16.9%) were related to a SCAE. The presence of a SCAE (vs. a non-SCAE) is associated with higher mortality (34 vs. 8%, p?<?0.001). The percentage of cases with one or more SCAE, the case mortality rate (%), and the incidence of each SCAE (per 106 days of sedative exposure), respectively, were benzodiazepines (14, 26, 13) [diazepam (13, 23, 31); lorazepam (15, 43, 14); midazolam (14, 20, 11)]; dexmedetomidine (40, 15, 13); and propofol (17, 39, 7). Propofol (vs. either a benzodiazepine or dexmedetomidine) was associated with more total SCAEs (268 vs. 126, p?<?0.001) but a lower incidence (per 106 days of sedative exposure) of SCAE (7 vs. 13, p?=?0.0001) and cardiac arrest [6.3 (benzodiazepine) vs. 6.7 (dexmedetomidine) vs. 1.4 (propofol), p?<?0.0001].ConclusionsSerious cardiac adverse events account for nearly one-fifth of intravenous sedative Food and Drug Administration's MedWatch Adverse Event Reporting System reports. These SCAEs appear to be associated with greater mortality than non-cardiac serious adverse events. Serious cardiac events may be more prevalent with either benzodiazepines or dexmedetomidine than propofol.

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Dataset Information

Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study.

Background

Objectives

Method

Results

Conclusion

Publications

Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study.

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