Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report

Abstract

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. Materials and 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. Conclusion 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.

Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

“…6,7,9 There has not been an nephrogenic systemic fibrosis report in newborns, infants, or toddlers with any GBCA to date. 10 The estimated glomerular filtration rate (eGFR) normalized to body surface area (BSA) is established in clinical practice to assess renal function in adults and is also used in the pediatric population. Normal eGFR values when normalized to BSA of 1.73 m 2 are known to be lower in young infants than in adults.…”

Pediatric MR Urography: Indications, Techniques, and Approach to Review

“…Delayed postcontrast images can also be used to generate 2D reformations that allow optimal visualization of anatomic structures of interest (eg, the ureteropelvic junction) and 3D reconstructions, including MIP and volumerendered images, which provide an overview of renal and urinary tract anatomic structures on a single image (Fig 2b). Postcontrast MR urography is generally inappropriate for children with acute kidney injury or chronic kidney disease and an estimated glomerular filtration rate less than 30 mL/min/1.73 m 2 because of the potential risk for nephrogenic systemic fibrosis (19)(20)(21)(22). Because MR urography is most often performed for children who have increased risk for impaired renal function, serum creatinine concentration should be measured and estimated glomerular filtration rate should be calculated with accepted formulas before contrast material administration (23).…”

Radioprotección y uso de contrastes en pediatría: qué, cómo y cuándo

“…Para el tratamiento y la prevención de la nefrotoxicidad inducida por el contraste intravenoso, el ACR 42 recomienda seguir las guías para adultos. • Existen muy pocos casos comunicados en la literatura sobre fibrosis sistémica nefrogénica relacionada con contrastes de Gd: 23 en pacientes con edades comprendidas entre los 8 y los 19 años 43 . El ACR recomienda seguir las mismas precauciones que para los adultos 42 .…”