Charlotte, NCGary has undergone 6 MRIs in the past two years and each time he was injected with a gadolinium-based contrast agent. Although Gary doesn't have the early signs of Nephrogenic Systemic Fibrosis, known as NSF (leathery skin painful and painful swelling in the legs and arms), he has developed some swelling and joint problems and worries that they are associated with MRI health risks.
According to the FDA, only those patients with severely impaired kidneys are at risk: healthy kidneys filter out the potentially toxic metal gadolinium. But some hospitals, such as Yale-New Haven Hospital that had several NSF patients die in recent years, have decided to "play it safe" and stopped buying one contrast agent (Omniscan, made by General Electric) back in 2006.
"Right after the dye is injected, it burns in your chest and the burning sensation travels down your body into your legs," says Gary. "As soon as they stop injecting the dye the burning sensation goes away and they tell you to drink lots of water and not take any meds for a day, to get the contrast agent out of your system. I asked the radiologist if there was any danger and he said not as long as you drink plenty of fluids to flush the gadolinium out of your kidneys. What if I can't flush it all out? What if I have an underlying kidney problem?"
Contrast Agent Lawsuits
"My lawyer said that some doctors working for the contrast agent manufacturers have known about NSF and gadolinium side effects for a long time but basically ignored them," says Gary.
Scientists concur that they don't fully understand how the disease starts, although nearly all NSF cases have involved patients with kidney problems who were injected with MRI contrast agents.
In 2006, Danish researchers noted that, over a four-year period, 25 patients in Denmark and Austria had suffered a rare and crippling disease after undergoing an MRI. The patients had all been injected with Omniscan, a General Electric product.
Since that time, more than 400 lawsuits have been filed in US federal courts against GE, Bayer and two other makers of similar drugs—about 300 are related to Omniscan. GE has conceded that a critical ingredient in Omniscan and other agents may be one of those factors that cause NSF, "but not necessarily an essential" factor.
While GE says it is investigating concerns about Omniscan, the company maintains there is no proof that the contrast agent causes disease. Meanwhile, Bayer HealthCare has settled more than 100 cases related to its contrast agent, Magnevist.
"My lawyer suggested that I see a dermatologist and get a deep skin tissue biopsy because my wrists and ankles constantly hurt," says Gary. "He said it is a painful procedure and at this point I'm undecided, but I just received the paper work if I want to go forward.
"Not very long after I had my last MRI, my left elbow swelled up and hurt so bad I couldn't sleep or bend my left arm. One doctor thought it is gout. but my family doctor said you don't get gout like that in your elbow, not to where I cannot straighten my arm all the way out. He said its probably RA, Or a bone spur. I disagree. I wake up in the morning with pain and swelling and to this day cannot straighten my arm.
I'm scheduled to have another MRI but this time, I am going to suggest not to get the contrast agent, after what I have learned about it. The pharmaceutical reps come into hospitals and push their product for profit and the medical community buys into it."
When it comes to Omniscan, Gary has a point. In 2007, the American College of Radiology issued guidance that Omniscan posed a greater risk than rival products. GE responded by making it easier for hospitals to receive financial incentives if they continued to purchase some Omniscan, according to court records and hospital executives.