ones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and D

For nearly ten years, researchers have been searching for the cause of a rare but potentially fatal condition which has been observed in kidney patients, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy. What starts with areas of thick and rigid skin on the arms and legs, could quickly progress to the point that the sufferer is left with extremely limited mobility or confined to a wheelchair.

It has recently been confirmed that gadolinium-based contrast agents administered for magnetic resonance imaging (MRI) and magnetic resonance angiograms (MRA) are the only known cause of the disabling and potentially fatal condition when given to those with impaired kidney function. What was once thought to be a relatively safe procedure has left many individuals with devastating injuries.

MRIs and MRAs are used to obtain highly detailed pictures of the tissues and veins in the body. The magnetic technology constructs two or three dimensional layouts, which have proven extremely beneficial since their inception in 1977.

In many cases, a contrast agent containing a paramagnetic metal, known as gadolinium, is injected into the body before the scan. Gadolinium tends to move into magnetic fields, which helps doctors differentiate between blood vessels and nearby tissue when interpreting the films. For most people, the contrast agents pose no danger and the gadolinium is eliminated in the kidney after the exam. However, for those with renal disease or impaired kidney function, the gadolinium may not be eliminated, increasing the risk of developing the extremely rare condition known as Nephrogenic Systemic Fibrosis.

NEPHROGENIC SYSTEMIC FIBROSIS (NSF/NFD)

The first reports of kidney patients developing areas of thick and hard skin which restricted movement were identified in 1997, and the condition was first discussed in medical literature in 2000. Initially it was thought to only affect the skin, and was referred to as Nephrogenic Fibrosing Dermopathy (NFD). As more information and data was gathered about the disorder, it was renamed Nephrogenic Systemic Fibrosis, as it also impacts other internal organs.

Nephrogenic Systemic Fibrosis (NSF/NFD) has only been identified in those with an unhealthy or recently transplanted kidney, and nearly all people diagnosed received an MRI or MRA with a gadolinium-based contrast agent within 18 months before the onset of symptoms. Early signs could include:
• Burning, itching, swelling of the skin
• Development of "thick skin" or "hard skin" which appears shiny
• Red or dark patches of skin
• Yellow spots on the whites of the eyes
• Stiff joints which cause trouble straightening or moving the limbs
• Deep pain in the hip bones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and Dr

ney function. What was once thought to be a relatively safe procedure has left many individuals with devastating injuries.

MRIs and MRAs are used to obtain highly detailed pictures of the tissues and veins in the body. The magnetic technology constructs two or three dimensional layouts, which have proven extremely beneficial since their inception in 1977.

In many cases, a contrast agent containing a paramagnetic metal, known as gadolinium, is injected into the body before the scan. Gadolinium tends to move into magnetic fields, which helps doctors differentiate between blood vessels and nearby tissue when interpreting the films. For most people, the contrast agents pose no danger and the gadolinium is eliminated in the kidney after the exam. However, for those with renal disease or impaired kidney function, the gadolinium may not be eliminated, increasing the risk of developing the extremely rare condition known as Nephrogenic Systemic Fibrosis.

NEPHROGENIC SYSTEMIC FIBROSIS (NSF/NFD)

The first reports of kidney patients developing areas of thick and hard skin which restricted movement were identified in 1997, and the condition was first discussed in medical literature in 2000. Initially it was thought to only affect the skin, and was referred to as Nephrogenic Fibrosing Dermopathy (NFD). As more information and data was gathered about the disorder, it was renamed Nephrogenic Systemic Fibrosis, as it also impacts other internal organs.

Nephrogenic Systemic Fibrosis (NSF/NFD) has only been identified in those with an unhealthy or recently transplanted kidney, and nearly all people diagnosed received an MRI or MRA with a gadolinium-based contrast agent within 18 months before the onset of symptoms. Early signs could include:
• Burning, itching, swelling of the skin
• Development of "thick skin" or "hard skin" which appears shiny
• Red or dark patches of skin
• Yellow spots on the whites of the eyes
• Stiff joints which cause trouble straightening or moving the limbs
• Deep pain in the hip bones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and D

anger and the gadolinium is eliminated in the kidney after the exam. However, for those with renal disease or impaired kidney function, the gadolinium may not be eliminated, increasing the risk of developing the extremely rare condition known as Nephrogenic Systemic Fibrosis.

NEPHROGENIC SYSTEMIC FIBROSIS (NSF/NFD)

The first reports of kidney patients developing areas of thick and hard skin which restricted movement were identified in 1997, and the condition was first discussed in medical literature in 2000. Initially it was thought to only affect the skin, and was referred to as Nephrogenic Fibrosing Dermopathy (NFD). As more information and data was gathered about the disorder, it was renamed Nephrogenic Systemic Fibrosis, as it also impacts other internal organs.

Nephrogenic Systemic Fibrosis (NSF/NFD) has only been identified in those with an unhealthy or recently transplanted kidney, and nearly all people diagnosed received an MRI or MRA with a gadolinium-based contrast agent within 18 months before the onset of symptoms. Early signs could include:
• Burning, itching, swelling of the skin
• Development of "thick skin" or "hard skin" which appears shiny
• Red or dark patches of skin
• Yellow spots on the whites of the eyes
• Stiff joints which cause trouble straightening or moving the limbs
• Deep pain in the hip bones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and D

er, it was renamed Nephrogenic Systemic Fibrosis, as it also impacts other internal organs.

Nephrogenic Systemic Fibrosis (NSF/NFD) has only been identified in those with an unhealthy or recently transplanted kidney, and nearly all people diagnosed received an MRI or MRA with a gadolinium-based contrast agent within 18 months before the onset of symptoms. Early signs could include:
• Burning, itching, swelling of the skin
• Development of "thick skin" or "hard skin" which appears shiny
• Red or dark patches of skin
• Yellow spots on the whites of the eyes
• Stiff joints which cause trouble straightening or moving the limbs
• Deep pain in the hip bones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and D

ones or ribs
• Generalized muscle weakness.

There is currently no known cure or consistently reliable treatment for Nephrogenic Systemic Fibrosis. It affects different people in different ways, and researchers are still gathering data and evaluating the best ways to manage the painful and debilitating condition. In some cases, the progression of the condition can be rapid, with the need for a wheelchair within weeks of the first symptoms appearing. It has also been responsible for death in some cases, as a result of complications associated with limited mobility and restrictions on movement.

FDA ISSUES ‘BLACK BOX’ WARNING

On May 23, 2007, the U.S. Food and Drug Administration (FDA) requested that gadolinium-based contrast agents contain a ‘black box’ warning, which is the strongest warning possible for a medical product. They cautioned that those with severe kidney insufficiency are at risk for developing the disease if they are given the contrast agents. The federal regulators recommend screening for kidney problems before one of the contrast agents is administered, and those with known impaired kidney function should carefully weigh the risks with their doctors against the benefits provided by the MRI with contrast.