As of April 3, 2007, the Food and Drug Administration has received another 65 cases of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). This confirms suspicions that contrast agents Magnevist, MultiHance, Omniscan, OptiMARK and ProHance containing gadolinium could cause this rare and potentially fatal disease as a side effect.
There are currently five FDA-approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These agents are approved for use during an MRI scan, but not for MRA. The FDA is asking health care professionals and patients to report possible cases of NSF/NFD through FDA's MedWatch program.
On May 29, 2006 the Danish Medicines Agency reported severe reactions to the common MRI contrast agent gadolinium. The agency reported 25 cases between Denmark and Austria of the extremely dangerous condition called Nephrogenic Systemic Fibrosis, sometimes called Nephrogenic Fibrosing Dermopathy. NSF or NFD is characterized by a number of diverse side effects including:
- Tightening and swelling of the skin, usually in the extremities
- Symmetrical skin lesions, commonly on the ankles and thighs
- Hypertension usually precedes skin lesions
- Reddened patches on the skin
- Calcification of muscle, skin, tendons
- Muscle weakness
- Thickening of the skin around the joints, which restricts movement
- Skin texture changes one not dissimilar to an orange peel
- Bone pain in the hips and ribs
- Yellow plaques near the eyes
- Burning, itching, sharp pains in affected areas
Magnetic resonance imagery is one of the most innovative technological breakthroughs in the history of medicine. High powered magnets force the water molecules in the body into virtually perfect alignment, giving doctors an incredibly detailed and accurate picture of the inner workings of the body without having to resort to dangerous and even potentially fatal exploratory surgery. Unfortunately, even MRIs cannot depict every condition with perfect clarity, and so doctors sometimes turn to contrast marker agents, like gadolinium.
Gadolinium is a colorless, non-radioactive, water-like liquid that doctors inject into the veins of some people undergoing MRIs. Contrast markers bond with damaged or diseased tissues, giving doctors a clearer picture of potential problems. Unfortunately, gadolinium has recently been linked to a number of serious side effects, including NSF. One of the problems with diagnosing a condition as complicated as NSF is that it can take anywhere between two weeks and three months for side effects to arise, and when they do they are easily confused with other, less dangerous conditions.
