Many Americans have had an MRI. But many Americans may not realize the dangers involved for some patients in the use of contrast agents with MRI. Contrast agents help healthcare professional see internal structures more clearly on an MRI. There are some basics that are important to know.
Nearly three years ago, the United States Food and Drug Administration (FDA) issued a request for a black box warning for the labeling of gadolinium-based contrast agents used for the enhancement of MRI imaging. The warning was targeted to patients with severe kidney insufficiencies and those involved in liver transplantation (both before and after surgery) or with chronic liver disease.
The FDA’s warning request was intended to generate warnings in the use of these contrast agents in patients with these severe kidney insufficiencies and other issues. Patients with severe kidney insufficiency that receive gadolinium-based agents are at risk for developing serious health issues including, nephrogenic systemic fibrosis (NSF) or another condition nephrogenic fibrosing dermopathy (NFD), from the use of gadolinium.
This 2007 warning request came after a June 2006 warning to health care professionals regarding some of these risks. These conditions are very serious indeed. The symptoms include serious problems with organs, skin and connective tissue that may not only result in broken bones, but seriously impact patient movement. Patients began to notice problems early on or some time after an MRI using these contrasting agents. Unfortunately, NSF or NFD can develop in patients that have been exposed to the contrast agent once, or multiple times.
At the time of the boxed warning request, the FDA said it had been “carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease.” Years later, patients are still suffering from the debilitating impact of these serious conditions when MRI contrast agents have been used on them and they were at risk for these conditions.
There are five gadolinium-based contrast agents used in the United States and these include: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).
If you would like to read more about the FDA’s black box warning request and about gadolinium, click here.
If you have had an MRI that included the use of gadolinium-based contrast agents and you are suffering from symptoms, please contact the lawyers of San Francisco’s Hersh & Hersh for a free consultation and more information.