CDC warns of rare skin disease risk to kidney patients

[okarol]

CDC warns of rare skin disease risk to kidney patients

03/07/2007

By Mike Stobbe
AP Medical Writer

ATLANTA - Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients.
More than two dozen dialysis patients in St. Louis over a four-year period contracted the unusual skin ailment, which causes burning and itching that can lead to discoloration and stiffening of the skin.
The U.S. Centers for Disease Control and Prevention investigated a number of the cases last year and found the illnesses were tied to a contrasting agent - basically a metallic dye - used for magnetic resonance imaging tests. The disease occurred in patients with advanced kidney disease who had undergone an MRI or a similar test.
''To the general public, it's not a big concern. But to somebody with kidney disease, we want to warn them not to get an MRI with the contrasting agent,'' said CDC spokeswoman Jennifer Morcone.
The dyes in question contain gadolinium, and are used in MRI scans that provide detailed pictures of internal organs and in similar scans that image blood vessels. The contrasting agents have been on the market since 1988.
Last year, the U.S. Food and Drug Administration issued a public health advisory following European reports of a rare skin disease in Austrian and Danish kidney patients who were given the agent.
The skin disease, called nephrogenic systemic fibrosis, is rare, but doctors think it may be under-recognized. A registry at Yale University has recorded about 215 cases to date.
Steroid treatments or kidney transplants have helped some patients recover.
The researchers noted that patients on peritoneal dialysis were more likely to develop the condition that those than on hemodialysis. CDC officials believe stricken patients weren't able to clear the contrasting agent from their body.

URL: http://www.gwinnettdailypost.com/index.php?s=&url_channel_id=43&url_article_id=25485&url_subchannel_id=&change_well_id=2

[Black]

Public Health Advisory
Update on Magnetic Resonance Imaging (MRI) Contrast Agents
Containing Gadolinium and Nephrogenic Fibrosing Dermopathy


The FDA has received additional information about a new disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD), which may occur in patients with moderate to end-stage kidney disease after they have had a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) scan with a gadolinium-based contrast agent.  An MRI scan provides clear and detailed pictures of internal organs.  An MRA test uses a gadolinium-based contrast agent to take detailed pictures of blood vessels.  During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. 

As of December 21, 2006, FDA has received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after they had an MRI or MRA with a gadolinium-based contrast agent.  Their NSF/NFD began from 2 days to 18 months after exposure to the contrast agent.  Many, but not all of these patients, received a high dose of the contrast agent; some received only one dose.   In light of these reports, FDA is notifying health care providers and patients of the following: 

Patients with moderate to end-stage kidney disease who receive an MRI or MRA with a gadolinium-based contrast agent may get NSF/NFD which is debilitating and may cause death.
Patients who believe they may have NSF/NFD should contact their doctor.  Patients who develop NSF/NFD have areas of tight, rigid skin and may have scarring of their body organs.   The signs of NSF/NFD also include: burning, itching, swelling, hardening and tightening of the skin; red or dark patches on the skin; yellow spots on the whites of the eyes; stiffness in joints with trouble moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or ribs; and muscle weakness.
When a patient with moderate to end-stage kidney disease needs an imaging study, select imaging methods other than MRI or MRA with a gadolinium-based contrast agent for the study whenever possible.  If these patients must receive a gadolinium-based contrast agent, prompt dialysis following the MRI or MRA should be considered.
The FDA asks health care professionals and patients to report possible cases of NSF/NFD to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

Worldwide, about 215 patients with NSF/NFD have been reported.  Of these reports, the medical histories of 75 of these patients were reviewed in detail, and all of the patients had received a gadolinium-based contrast agent for an MRI or MRA.  Researchers have identified gadolinium in skin biopsies of patients with NSF/NFD.

Why NSF/NFD occurs in patients with moderate to end-stage kidney disease who receive gadolinium-based contrast agent is not yet known.  The FDA is working with expert scientists to gather additional information about NSF/NFD.

Currently there are five FDA approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance.  These contrast agents are FDA approved for use during an MRI scan, but not for use during an MRA scan.  Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that there is a potential for NSF/NFD to occur with the use of any of the approved gadolinium-based contrast agents. 

You can find more details about NSF/NFD and gadolinium-based contrast agents in FDA’s Information for Healthcare Professionals.

http://www.fda.gov/cder/drug/advisory/gadolinium_agents_20061222.htm

[kitkatz]

Great, so when they are trying to help me, they can kill me off!


Be aware many radiologists are not aware of this concern for kidney patients. When I went in for an MRI this year the radialogist wanted my paperwork I had taken off of the net to read. I gave it to him. Please let people know you are a kidney patient before the start the MRI or give you anything by IV beforehand.  Make them stop and discuss it with you!

[Amanda From OZ]

Yikes! The two times Ive had contrast dye injected into me, i came out with some itchy hives because i had an allergic reaction to them......! This isn't the same thing is it? aha I'm getting itchy just thinking about it!!!   

[goofynina]

Yikes! The two times Ive had contrast dye injected into me, i came out with some itchy hives because i had an allergic reaction to them......! This isn't the same thing is it? aha I'm getting itchy just thinking about it!!!   

Oh Amanda, it can be fleas