Injuries From Gadolinium Injectable Dye

Gadolinium is a non-radioactive, water-like liquid injected into the veins of patients undergoing MRIs and MRAs “with contrast.” Contrast markers bond with damaged or diseased tissues, giving doctors a clearer picture of potential problems, many times resulting in an easier and more accurate diagnosis.

Normally, gadolinium is expelled from a person’s body within hours, with no damage or little risk. Unlike others, people with kidney problems have difficulty expelling the agent from their system. Maintaining this chemical agent in one’s system for too long a period of time can lead to a condition known as Nephrogenic Systemic Fibrosis (NSF), which is also known as Nephrogenic Fibrosing Dermopathy (NFD). This condition leads to severely restricted joint movement, possible confinement to a wheelchair and even death.

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

On May 23, 2007, the FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of NSF to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.

If you suffer any of the symptoms described above or have been diagnosed with NSF after having received an MRI / MRA with Gadolinium contrast dye, Claudine Homolash can help you. Please contact Claudine Homolash at (215) 790-7300, for a free consultation.