The element gadolinium is used as a contrast agent for magnetic resonance imaging and magnetic resonance angiography, injected into patients needing these scans for diagnosis of possible health problems. Gadolinium was approved by the United States Food and Drug Administration for this use in 1988. The medical community embraced gadolinium because iodine-based contrast agents sometimes caused kidney failure or severe allergic reactions. However, gadolinium also turned out to cause life-threatening reactions, and numerous lawsuits have been filed over this substance.
In 2007, the FDA issued a black box warning for the five gadolinium-based contrast agents used in MRIs. The most serious action aside from a recall, the black box labeling warned of a rare disorder causing very debilitating and even fatal reactions. This disorder is called nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD), and it often occurred in patients who were known to have moderate or severe kidney disease. Kidney disorders prevent gadolinium from being removed by the body.
NSF/NFD causes increased formation of fibrous connective tissue in the skin and internal organs. People may first begin noticing sensations in the skin such as burning, itching, swelling and tightening. Eventually, skin can become shiny and hard, extremely painful, with red or discolored patches. Skin hardening can lead to joint pain and immobility.
This excessive connective tissue also affects the lungs, heart and diaphragm, causing breathing difficulties which can result in death. These symptoms can begin as long as 18 months after exposure to the contrast agent. As of 2009, no effective treatment has been discovered.
The 2007 black box labeling followed a health advisory issued by the FDA in 2006, stating that the agency had received 90 reports of patients with kidney disease who developed NSF after being injected with gadolinium-based contrast agents. Over 100 more patients worldwide had reported developing NSF, all of whom had been exposed to gadolinium-based contrast agents. People have been diagnosed with kidney disease upon developing symptoms after the MRI, and may have had impaired kidney function previously which went undiagnosed.
Other Side Effects
More common and milder side effects from gadolinium used in MRIs include facial swelling, headache, nausea, and a rash or hives. Rarely, light-headedness and low blood pressure can occur. Fewer than one in 1000 patients have an allergic reaction to gadolinium, with symptoms of hives, facial swelling and difficulty breathing.