Magnetic resonance imaging, or MRI, scans are used worldwide in hospitals to help with the diagnosis and treatment of patients. Often when a patient needs to undergo an MRI scan, he or she must ingest or be administered a dye, called a contrasting agent, which will allow the doctor a clearer view of his or her insides on the scan – as well as increase the chances that a doctor will spot a problem area or discrepancy and be able to treat it quickly and successfully. However, many contrasting agents – the brands Magnevist, ProHance, OptiMARK, MultiHance, and Omniscan – contain gadolinium, which comes with a risk of side effects.
The Food and Drug Administration offered a gadolinium-related warning to healthcare providers in June of 2006 after the Danish Health Authority provided evidence of 25 gadolinium-related cases of nephrogenic systemic fibrosis, or NSF – a condition that causes hardening of the skin, organs, and other tissues in the body. This condition is permanent, debilitating, and there is no known cure. Patients who are experiencing renal failure or have other kidney problems are especially at risk for developing gadolinium-related NSF, leading the Food and Drug Administration to issue a warning to doctors, urging them to know the warning signs and to determine whether or not it is safe to use a gadolinium product on a patient based on his or her current health.
The Food and Drug Administration also required that manufacturers of gadolinium-based contrasting agents, or GBCAs, include a warning label on both the packaging and inner label of their products, warning users of the risks associated with NSF, especially in the cases of patients with kidney problems and renal failure. These warnings go into more detail about potential Gadolinium side effects and are specific about the risks associated with the product, allowing doctors to make careful decisions about who they treat with gadolinium-based products and who they do not allow to be treated with these products.
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