FDA Warns From Renal Fibrosis Induced By Gadolinium-Based Contrast Agents

The Food and Drug Administration (FDA) has declared an important warning revealing that gadolinium-based contrast agents (GBCAs), used for radiology imaging, carry a high risk for developing renal fibrosis specially for people with prior kidney disease. This is the second time that FDA highlights the dangers of GBCAs; last year it mandated black label warnings for these hazardous agents. The FDA’s warning has specifically determined Magnevist, Omniscan, and Optimark brands of GBCA as forbidden for use in patients with acute renal problems or chronic severe renal disease. This is due to an FDA risk review of those brands. Furthermore, the FDA pointed out in its press statement that assessing other brands is being performed. Currently, the FDA is revising the black label warning on all brands of GBCA, now it recommends screening patients for kidney impairment before administration. The FDA has also offered new GBCA guidelines for imaging facilities.