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Gadolinium- based MRI Contrast Agents Linked to Severe Skin Disorder NSF/NSD

By Halli Brownfield

Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy(NFD) is a skin and joint disease associated with the use of gadolinium based contrast agents in patients with renal insufficiency. The Clinical Journalof the American Society of Nephrologystates that "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles." NSF/NFD is characterized by areas of tight and rigid skin that makes it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inabiltiy of body organs to work properly and can lead to death.

Other 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 and trouble moving or straightening the arms, hands, legs, or feet
• Pain deep in the hip bones or ribs
• Muscle weakness

Gadolium-based contrast agents are used in MRIand MRA scans. An MRI scan is performed to take a clear detailed picture of a patient's internal organs and tissue and an MRA is used to take a detailed picture of a patient's blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into the patient's vein so blood vessels can be distinguished from other nearby tissues. Five gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:

• Omniscan
• OptiMARK
• Magnevist
• ProHance
• MultiHance

None of these agents are approved by the FDA for MRA. The dose of gadolinium-based contrast agent given to patients undergoing an MRA is often higher (up to three times) than the approved dose for MRI.

The United States Food and Drug Administration (FDA) in 2006 acknoweldged in a Public Health Advistory that, at the time, there were 200 reports worldwide of NSF/NFD. These cases developed following patient exposure to various gadolinium-based contrast agents. The report conceded that many of these were serious and some fatal. In May of 2007, the FDA advised manufacturers of gadolinium-based contrast agents to place a "Boxed Warning" in their product directionsabout the risks of NSF/NFD. The FDA said that warning should state that use of the contrast agents in patients with severe renal insuffciency increases the risk of NSF/NFD, that the disease is debilitating and sometimes fatal, and that it affects skin, muscle, and internal organs. The FDA instructs that these gadolinium based contrast agents should be avoided unless diagnostic information is essential and cannot be obtained without a non-contrast enhanced MRI. Helath care professional are also advised to screen patients for renal disfunction before administering these gadolium-based drugs, not to exceed the recommended dosage, and to discuss with "at risk" patients the risk and symptoms of NSF.

Lawsuits against the manufacturers of these gadolinium based contrast agents have beenfiled across the country alleging that these manufacturers knew or should have known of the risks of developing NSF/NFD. These lawsuits also allege thatgadolium manufacturersshould have warned consumers and health care providers of these risks. These cases have been consolidated and transferred to federal court in Cleveland, Ohio.

For a recent news report on NSF/NFD see:

http://www.myfoxcleveland.com/myfox/pages/Home/Detail;jsessionid=8A340206B2CE23E3B64759771A510297?contentId=6580262&version=1&locale=EN-US&layoutCode=VSTY&pageId=1.1.1&sflg=1

Anyone who has undergone an MRI or MRA and exhibits symptoms of NSF/NFD should contact a lawyer immediately in order to preserve their legal rights.

Originally posted at InjuryBoard by Halli Brownfield

Full post as published by Cleveland Personal Injury Lawyer on June 04, 2008 (boomark / email).