Warnings for Gadolinium-Based Contrast Agents

By Staff

10/20/2010

US Pharm. 2010;35(10):124.

The FDA is requiring that gadolinium-based contrast agents (GBCAs), used with magnetic resonance imaging or magnetic resonance angiography, carry a new label warning of the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition that can result if the drug is administered to certain patients with kidney disease. Three of the GBCAs (Magnevist, Omniscan, and Optimark) will be described as inappropriate for patients with acute kidney injury or chronic severe kidney disease. NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness.

The FDA recommends that health care professionals estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function; avoid use of GBCAs in patients suspected or known to have impaired drug elimination, unless the imaging is essential and not available without contrast; monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease; and administer a GBCA only once during an imaging session.