Gadolinium MRI NSF

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Gadolinium NSF MRI Class Action Lawsuit Recall Lawyer Information

Gadolinium MRI NSF Contrast Agent Dangers

Gadolinium is a contrast agent often used in MRI’s to improve evaluation. The contrast agent. Prior to an MRI, the contrast agent is injected via an intravenous line in the arm or hand. Not all MRI’s require a contrasting agent or cause NSF.

In May 2007, the FDA issued a black box warning on gadolinium MRI contrast agents because the contrast agent had been linked to a serious kidney disorder, nephrogenic systemic fibrosis,and side effects in patients with kidney failure. The disorder is irreversible and has no known treatment. The lawsuits are related to the FDA warnings and are as follows:

Boxed Warning:

Exposure to GBCAs (gadolinium-based contrasting agents) increases the risk for NSF in patients with:

  • acute or chronic severe renal insufficiency (glomerular filtration rate acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
  • NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
  • Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).
  • Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
  • When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any readministration.
  • Additional New Warnings:
  • Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA.
  • For patients receiving hemodialysis, healthcare professionals may consider prompt hemodialysis following GBCA administration in order to enhance the contrast agent’s elimination. However, it is unknown if hemodialysis prevents NSF.
  • Determine the renal function of patients by obtaining a medical history or conducting laboratory tests that measure renal function prior to using a GBCA.
  • The risk, if any, for developing NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.
  • Post-marketing reports have identified the development of NSF following single and multiple administrations of GBCAs. These reports have not always identified a specific agent. Where a specific agent was identified, the most commonly reported agent was Omniscan, followed by Magnevist and OptiMARK. NSF has also developed following the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. The distribution of the number of reports for the individual GBCAs may relate to multiple factors, including more limited use of some GBCAs, under-reporting of NSF, characteristics of the agent and a lack of patients’ complete GBCA exposure history.

Presently, the FDA has approved 5 gadolinium-based contrasting agents for use in MRI procedures: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The GBCA’s contain the black-box warning so that doctors and other health-care professionals are aware of the potential health dangers in using them in patients with kidney disease.

Healthcare professionals believe the only manner in which nephrogenic systemic fibrosis is contracted is through the introduction of the contrasting agent gadolinium. NSF is a painful and potentially fatal disease that affects the skin and internal organs. Initially, the skin thickens and hardens followed by the same in the body’s internal organs. NSF was first identified in 1997 and there has yet to be found an effective treatment for the debilitating disease. The initial reports of serious health problems related to the gadolinium contrasting agents was reported by Dutch authorities in 2006.

If you’ve had an MRI containing a gadolinium-based contrasting agent and you have had renal disease, be vigilant for the following symptoms: swelling, hardening, or tightening of the skin, red or dark patches on your skin, burning or itching, yellow raised spots on the whites of your eyes, joint stiffness accompanied by difficulty in mobility, deep hip or rib pain, and muscle fatigue.

If you’ve experienced these symptoms, call your healthcare professional immediately.