FDA calls for ‘black box’ warning on gadolinium agents

Article

All five gadolinium-based MR agents on the U.S. market may soon carry a “black box” warning describing the risk of developing nephrogenic systemic fibrosis for patients with severe renal disease.

All five gadolinium-based MR agents on the U.S. market may soon carry a "black box" warning describing the risk of developing nephrogenic systemic fibrosis for patients with severe renal disease.

The FDA yesterday asked the manufacturers to carry the warning and to prospectively collect data on patients exposed to these contrast agents to find out if they had any renal insufficiency. The goal, according to the agency, is to more accurately estimate the magnitude of the risk of developing NSF for patients with kidney disease. The manufacturers and their agents are Bayer Schering Pharma (Magnevist), Bracco (MultiHance and ProHance), GE Healthcare (Omniscan), and Mallinckrodt (OptiMark).

Cases of NSF have been reported following the administration of each of these agents, but FDA investigators are not certain whether all are directly linked to the condition. Some adverse event reports have incomplete patient histories of agent exposure, and other reports indicate that patients received more than one type of agent prior to an NSF diagnosis.

The FDA stated that only patients who have severe renal insufficiency appear to be at increased risk for developing the disease, which causes fibrosis of the skin and connective tissues, and can often be fatal. This is a change from December 2006, when the agency issued a warning that patients with moderate renal insufficiency were at risk for developing NSF. Since then, the FDA has learned that those patients thought to have moderately insufficient kidney function actually were in acute renal failure at the time they received a gadolinium agent.

Gadolinium-based agents are manufactured by a chelation process in which large organic molecules form a stable complex around the metal, reducing its toxicity potential. This stable complex is eliminated predominantly via the kidneys.

The requests demonstrated the FDA's "continuing vigilance about ensuring the safety of drug products once they enter the marketplace," according to Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

The FDA said its investigators will continue to evaluate new reports of NSF and may request additional studies and/or labeling changes.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Related Content
© 2025 MJH Life Sciences

All rights reserved.