The FDA is banning the use of three major brands of MRI contrast agent on patients with kidney problems, and is forcing other manufacturers to change their labels to bring more attention to the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal side effects of the gadolinium-based contrasting agents.
On September 9, the FDA issued a drug safety communication that contraindicated the use of Omniscan, Magnevist and Optimark among individuals with chronic and acute kidney problems due to the high risk of NSF and required label changing for all the rest. The new warnings mark a rare occasion when FDA decided that a black box warning was not sufficient.
The label changes apply to all gadolinium-based contrast agents (GBCAs), which are solutions that are injected before an MRI scan is performed to improve the results. The new label warning will tell healthcare professionals to screen patients before injecting a GBCA to identify those suffering from acute kidney injury or chronic, severe kidney disease.
The FDA is describing three GBCAs as inappropriate for use with anyone with kidney injuries or kidney disease under any circumstances: GE Healthcare’s Omniscan, Bayer’s Magnevist and Covidien’s Optimark.
The three GBCAs identified by the FDA, which are manufactured by GE Healthcare, Bayer and Covidien, have been associated with the highest number of NSF cases, according to the American College of Radiology (ACR). Omniscan has been linked to 382 cases of NSF out of approximately 13 million doses. Magnevist has been associated with 195 NSF cases out of 23 million doses, and Optimark has been linked to 35 cases out of 4.7 million doses.
Nephrogenic systemic fibrosis, which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a GBCA among individuals with impaired kidney function. It is associated with a hardening and thickening of the skin which restricts movement over time. There is no cure for the painful and debilitating condition, and in many cases it results in death over time.
The manufacturers of all types of gadolinium-based agents were required by the FDA to add the same “black box” warning about the risk of NSF from MRI with contrast in the United States in 2007, indicating that individuals with severe kidney problems could develop NSF.
Hundreds of nephrogenic systemic fibrosis lawsuits have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, GE Healthcare’s Omniscan has been associated with the most lawsuits over NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.