Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report.
BACKGROUND
Nephrogenic systemic fibrosis is a fibrosing disorder associated with exposure to gadolinium-based contrast agents in people with severely compromised renal function.


OBJECTIVE
The purpose of this study was to determine the reported number of cases of nephrogenic systemic fibrosis in children using three distinct publicly available data sources.


METHODS
We conducted systematic searches of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the International Center for Nephrogenic Systemic Fibrosis Research (ICNSFR) registry and published literature from January 1997 through September 2012. We contacted authors of individual published cases to obtain follow-up data. Data sets were cross-referenced to eliminate duplicate reporting.


RESULTS
We identified 23 children with nephrogenic systemic fibrosis. Seventeen had documented exposure to gadolinium-based contrast agents. Six children had been reported in both the FAERS and the literature, four in the FAERS and the ICNSFR registry and five in all three data sources.


CONCLUSIONS
Nephrogenic systemic fibrosis has been rarely reported in children. Although rules related to confidentiality limit the ability to reconcile reports, active pharmaco-vigilance using RADAR (Research on Adverse Drug events And Reports) methodology helped in establishing the number of individual pediatric cases within the three major data sources.
Department of Dermatology, Northwestern University Feinberg School of Medicine, 676 N. Saint Clair St., Ste. 1600, Chicago, IL, 60611, USA.
Beatrice
B
Nardone
Elise
E
Saddleton
Anne E
AE
Laumann
Beatrice J
BJ
Edwards
Dennis W
DW
Raisch
June M
JM
McKoy
Steven M
SM
Belknap
Christian
C
Bull
Anand
A
Haryani
Shawn E
SE
Cowper
Ali K
AK
Abu-Alfa
Frank H
FH
Miller
Victoria
V
Godinez-Puig
Vikas R
VR
Dharnidharka
Dennis P
DP
West
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D017677:Age Distribution; D002648:Child; D005260:Female; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D019221:Mandatory Reporting; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000453:epidemiology*; D018570:Risk Assessment; D017678:Sex Distribution; D014481:United States / Q000453:epidemiology
D005682:Gadolinium