Warning: Declaration of My_Walker::start_el(&$output, $item, $depth, $args) should be compatible with Walker_Nav_Menu::start_el(&$output, $data_object, $depth = 0, $args = NULL, $current_object_id = 0) in /home2/ajnrblog/public_html/ajnrdigest/wp-content/themes/ajnr/functions.php on line 258
Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration - AJNR News Digest
September-October 2020
Patient Safety

Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration

Krefting picture

Ira Krefting

This study was initiated following the 2009 FDA Advisory Committee on Nephrogenic Systemic Fibrosis and the subsequent safety labeling changes contraindicating gadodiamide (Omniscan), gadopentetate (Magnevist), and gadoversetamide (Optimark) in patients with severe renal failure (estimated glomerular filtration rate [eGFR] < 30). Gadobenate (MultiHance), structurally related to gadopentetate, was not uniquely associated with nephrogenic systemic fibrosis (NSF) reports and was not contraindicated. However, gadobenate was approved in 2004 and therefore lacked the longer market exposure of the contraindicated gadolinium-based contrast agents (GBCAs). The study was performed to further evaluate the NSF risk with gadobenate. When gadolinium retention was recognized as a potential safety issue, measuring gadolinium in the skin was added to the protocol.

This study joins the body of evidence demonstrating the rarity of NSF associated with the noncontraindicated GBCAs in patients with varying degrees of renal failure based on levels of eGFR.

The study was included as a supporting publication of a large, VA-sponsored review of NSF risk in patients with renal failure and other comorbid conditions.1

GBCA safety concerns now center on gadolinium retention and exposure to gadolinium in pregnancy. At the request of the FDA, the gadolinium contrast manufacturers are sponsoring a 5-year clinical study of neurologic function in patients with chronic illnesses undergoing routine, repetitive GBCA MRIs. GBCAs in pregnancy are also being evaluated.

Findings will be presented at the Global Summit on Regulatory Science 2020 held virtually on September 28–30.

Reference

  1. Lunyera J, Mohottige D, Alexopoulos A-S, et al. Risk for nephrogenic systemic fibrosis after exposure to newer gadolinium agents:  a systematic review. Ann Intern Med 2020;173:110–19

Read this article at AJNR.org …