Magnetic resonance imaging (MRI) scans are widely used by doctors throughout the United States to provide detailed body imaging to help identify and diagnose medical conditions. In providing greater contrast between the soft tissues of the body than computed tomography (CT) scans, MRIs have proven to be significantly useful. However, the Food and Drug Administration (FDA) has recently warned doctors that some contrast agents injected into patients who have kidney disease prior to their MRI scan may lead to a rare and occasionally fatal disorder.
According to an MSNBC report, the FDA is adding the strongest warning label to imaging agents containing gadolinium, stating that they should not be used in patients with weakened kidney function. “Nephrogenic fibrosing dermopathy” has been reported in patients with kidney problems who were given the gadolinium agent. This condition, although rare, can be fatal in some cases as it causes a patient’s skin to harden, as well additional tissue growth on joints, eyes, and internal organs. Although a kidney transplant may slow the disease and even reverse it in some instances, there is no known treatment for nephrogenic fibrosing dermopathy.
Five contrast agents have been used for MRI scans since the FDA approved them in 1988. The nephrogenic ailment has been reported from the use of all five agents. However, the FDA has noted that the following three agents present the highest risk: Bayer Healthcare’s Magnevist, General Electric Healthcare’s Omniscan and Covidien’s Optimark.
Included among the responsibilities of a radiologist and/or ordering physician, is to ensure that pharmaceutical agents are used safely, and, not in circumstances where the patient’s life may be put at risk. With the new warning label for MRI agents, physicians must make sure that patients with kidney conditions do not receive gadolinium before being scanned. The new FDA label has been reported to reinforce already existing doctor recommended guidelines for screening patients for kidney problems before administering the MRI contrast agents. Patients with weakened kidney function who were not adequately screened and now suffer from the complications of nephrogenic fibrosing dermopathy as a result may be entitled to legal recourse.
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