FDA Orders Label Warning To Be Placed On MRI Contrast Agents

The FDA announced recently that four gadolinium-based contrast agents (GBCAs) used during magnetic resonance imaging (MRIs) will feature a new label warning about the risk for nephrogenic systemic fibrosis (NSF) in certain patients with kidney disease, Nephrogenic systemic fibrosis is a rare and serious condition in which patients develop large areas of hardened tissue within their skin, joints, eyes, and internal organs Although the cause of the condition is not fully known, it typically results from exposure to a substance known as Gadolinium. Godolinium is the main ingredient in the four contrast agents to receive warning labels. .Nephrogenic systemic fibrosis is potentially fatal.

It is not uncommon for a patient to be injected with a contrast agent before undergoing a magnetic resonance imaging scan (MRI). Contrast agents alter the relaxation times of tissues and body cavities where they are present and are therefore sometimes injected into a patient’s body to help improve the visibility of internal body structures during the procedure.

The effect of GBCAs on patients with kidney disease is well known. Most doctors order at-risk patients to have their kidney functions tested prior to MRI imaging to avoid any potential problems with the contrast. Furthermore, doctors and MRI technicians are typically very conservative with their use of contrast on patients with kidney disease However, patients with undiagnosed kidney disease are still at risk of accidentally receiving Godolinium contrast. In most cases of nephrogenic systemic fibrosis, a patient with undiagnosed kidney disease did not have their kidney function tested, underwent an MRI for an unrelated condition, and later began to suffer effects from the contrast.

The FDA is hoping that the new warning labels with encourage physicians to test more patients’ kidney functions before administering contrast. Specifically, four GBCAs, gadofosveset trisodium (Ablavar; Lantheus Medical Imaging), gadoxetate disodium (Eovist; Bayer Healthcare Pharmaceuticals), gadobenate dimeglumine (Multihance; Bracco Diagnostics), and gadoteridol (Prohance; Bracco Diagnostics), will feature the new warning label. Furthermore, the FDA announced that three GBCAs, gadopentetate dimeglumine (Magnevist; Bayer Healthcare Pharmaceuticals), gadodiamide (Omniscan; GE Healthcare), and gadoversetamide (Optimark; Mallinckrodt) may also place some patients at risk for developing nephrogenic systemic fibrosis and should be contraindicated for patients with chronic kidney disease or acute kidney injuries. According to the FDA, the new warning label will also applies to magnetic resonance angiography (MRA). MRAs are used to detect heart problems, stroke, and vascular disease. Both MRIs and MRAs can be performed without using a contrast agent.

I am glad that the FDA is finally ordering warning labels to be placed on these contrast agents. The FDA first alerted the public to a possible link between nephrogenic systemic fibrosis and GBCAs in 2006. However, they were slow to take any more action than that despite the fact that the following year researchers reported finding gadolinium in the skin of patients with the disease. I hope that the new labels with encourage those physicians that continually fail to test their patients’ kidney function prior to MRI testing to smarten up and take this extra step. If your doctor has ordered you to have an MRI and you think that you could be at risk of kidney disease, demand to be tested before hand. It could save your life.