| If you have had an MRI (magnetic resonance imaging) | | | | warning be added to all Gadolinium-based contrast |
| or MRA (magnetic resonance angiography) with | | | | agent labels concerning the life-threatening risk |
| contrast (dye injected into the patient so the doctor | | | | associated with the use of contrast dyes containing |
| can clearly see internal organs, tissues and bones) you | | | | Gadolinium. |
| may be at risk of a fatal, incurable disease. | | | | The warning states that patients with severe kidney |
| Nephrogenic systemic fibrosis (NSF) also known as | | | | insufficiency who receive Gadolinium-based agents |
| nephrogenic fibrosing dermopathy (NFD) occurs in | | | | are at risk for developing the debilitating, potentially fatal |
| kidney patients who have an MRI with contrast. | | | | disease known as Nephrogenic Systemic Fibrosis |
| An article at tells the story of Jeanie Deason who | | | | (NSF). |
| developed NSF/NFD and has filed a lawsuit against | | | | The required warning includes advice to "avoid the use |
| the makers of the contrast dye. Jeanie's legs and right | | | | of GBCA's (Contrast agents containing Gadolinium) |
| arm are now "frozen in a bent position." Her condition | | | | unless the diagnostic information is essential and not |
| has so deteriorated that she requires 24 hour | | | | available with non-contrast enhanced magnetic |
| assistance. She spends her days bedridden, limbs | | | | resonance imaging (MRI). |
| throbbing, getting up only when her parents help her to | | | | Although the FDA requires the warning, this use of |
| the bathroom. | | | | Gadolinium containing contrast agents is still allowed |
| A doctor recommended therapy to help with Deason's | | | | and they are frequently used. |
| condition; however, TennCare, Tennessee's Medicaid | | | | Lawsuits filed in federally supervised multi-district |
| managed care program, refused for two years to pay | | | | litigation in Cleveland allege the manufacturers knew of |
| for her treatment claiming it was experimental. Finally, in | | | | the dangers long before the FDA imposed warnings. |
| April, a Tennessee judge said TennCare must pay | | | | "Makers of the contrast dye knew how toxic it was; |
| because the treatment is medically necessary. | | | | they knew the results could be catastrophic," said |
| Although there is no known cure for NSF, Deason's | | | | Seattle Super Lawyer Ken Selander who works with |
| physician, Dr. John Zic, an assistant professor of | | | | a group of lawyers around the country representing |
| dermatology at Vanderbilt University, believes he can | | | | victims of the disease. |
| give Jeannie some relief through "extracorporeal | | | | Those most at risk for the disease, kidney patients, are |
| photopheresis". It takes blood from her body, exposes | | | | legion, according to the National Kidney Foundation |
| it to ultraviolet rays, then returns it to her. This helps her | | | | who reports that some 20 million people-1 in 9 |
| body's immune system fight the disease. It can cost | | | | American adults-have chronic kidney disease and |
| $8000 for a single treatment. | | | | another 20 million are at risk for developing it. |
| In Denver, Greta Carolus, suffering from kidney failure, | | | | Of those at risk, the ones most in need of the warning |
| was injected with a contrast dye containing Gadolinium, | | | | are the 300,000 people in the United States who are |
| a rare metal. Four days after her MRI she was | | | | dependent on kidney dialysis to remove toxins from |
| hospitalized, diagnosed with NSF and found herself in a | | | | their blood. Typically, patients must visit a clinic several |
| wheelchair reports an article at "I wouldn't wish this on | | | | times a week for 4-hour periods while their blood is |
| anybody; my worst enemy I wouldn't wish this on. This | | | | cleaned. |
| is just a terrible disease," says Greta. | | | | Initial symptoms of the disease include high blood |
| Kidney patients are most at risk for this disease as the | | | | pressure, muscle weakness and thick hardened skin. |
| toxic contrast dye is expelled through the kidneys and | | | | With time victims may suffer pain, burning and itching in |
| if they aren't working the poison does not leave the | | | | affected areas. With more time, victims may |
| body. | | | | experience stiffness in skin and joints which completely |
| The United States Food and Drug Administration | | | | immobilizes them. Some suffer death. |
| (FDA) began issuing health advisory warnings on all | | | | If you or a loved one has kidney disease and |
| MRI contrast dyes (also known as "contrast agents" | | | | experienced severe skin reactions after an MRI you |
| or "contrast mediums") containing Gadolinium. | | | | should see a dermatologist at once. He can order the |
| On May 23, 2007, the FDA ordered that a black box | | | | simple test which confirms you have the disease. |