The government has ordered a “black box” warning for gadolinium-based contrast agents used in MRI and MRA exams because the injected dye may cause kidney-disease patients to develop a debilitating and potentially fatal disease.
The disease, known as nephrogenic systemic fibrosis, or NSF, causes patients to develop thickening of the skin and connective tissues, affecting their ability to move or resulting in broken bones. It can also affect internal organs. There is no cure for NSF and no consistently effective treatment.
Symptoms of NSF include tightening and swelling of the skin generally in the extremities, thickening of the skin around joints, red skin patches, burning or itching, calcification of soft tissue, skin lesions, muscle weakness, deep bone pain in the hips or ribs, yellow plaques near the eyes and fluctuating hypertension.
The U.S. Food and Drug Administration (FDA) noted that the injected contrast agents, also known as contrast dyes, containing gadolinium are favored in magnetic resonance imaging (MRI) tests for people with chronic kidney disease to enhance the images, particularly MRIs of the brain, spine and associated tissues. The dyes also are used in magnetic resonance angiograms, or MRAs.
The FDA said reports have identified the development of NSF following even a single injection of gadolinium agents.
It identified five gadolinium-based contrast agents: gadopentetate dimeglumine, or Magnevist, made by Bayer Schering Pharma; gadodiamide, Ominiscan, by GE Healthcare; gadoversetamide, or OptiMARK, by Mallinckrodt, Inc.; gadobenate dimeglumine, or MultiHance, and gadoteridol, ProHance, by Bracco Diagnostics Inc.
The FDA said it had received no reports of NSF in patients with normal kidney function or those with mild to moderate kidney insufficiency.
In addition to gadolinium, the FDA in October 2007 announced labeling changes for microbubble contrast agents Definity and Optison used in echocardiography because of a link to hundreds of serious cardiopulmonary events and at least 11 deaths.
The FDA noted that in four of the fatalities, patients died of cardiac arrest within 30 minutes of receiving Definity, made by DuPont Pharmaceuticals. There were 190 non-fatal serious reactions reported following the use of Definity and nine incidents involving Optison, made by GE Healthcare.
Many of those cardiac problems occurred within minutes of patients receiving the microbubble contrast agents. The FDA said DuPont and GE Healthcare would conduct post-marketing safety studies to monitor the risk of the contrast agents.
Kline & Specter, PC, with some 30 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug and defective medical device lawsuits. At this time, Kline & Specter is not accepting claims involving injuries caused by Gadolinium and contrast dyes.