Development of Serious and Sometimes Fatal Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy

摘要

The Food and Drug Administration (FDA) has learned of 25 foreign cases of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with renal failure who underwent magnetic resonance angiography (MRA) with Omniscan. Omniscan and other gadolinium-containing contrast agents are FDA approved for use in magnetic resonance imaging (MRI) but not for MRA. Physicians should carefully assess the need for performing MRI with contrast in patients with advanced renal failure (those currently requiring dialysis or with a glomerular filtration rate [GFR] <=1.5 cc/min) and administer the minimal needed dose of contrast agent if MRI with contrast is necessary. The FDA is further evaluating the possible link between the use of gadolinium-containing contrast agents and development of NSF/NFD.