FDA requires new warnings on gadolinium-based contrast agents
September 15th, 2010 by Jennifer Walker-Journey
Five years after the food and Drug Administration first alerted medical professionals about a possible link between gadolinium-based contrast agents (GBCAs) and a serious kidney dysfunction known as Nephrogenic Systemic Fibrosis (NSF), the agency this week announced it is requiring changes to the drug’s professional labeling in an effort to minimize the risk. The agency noted that NSF after GBCAs has not been reported in patients with normal kidney function, and that patients at greatest risk for developing the condition after GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.
GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). The drugs cited by the FDA include Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), and Prohance (gadoteridol). All five GBCAs are now required to add a new boxed warning and new warnings section to their labels to describe the risk of developing NSF.
The updated safety label will alert health care professionals that before administrating GBCA to patients, they should first screen patients to identify those with acute kidney or chronic, severe, kidney disease.
Any adverse events with GBCAs or any other medication should be reported to the FDA’s MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.