Multihance (gadobenate dimeglumine) Injection, Solution (Bracco Diagnostics Inc.)

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS linked to patients who received gadolinium-based contrast agents:

The Food and Drug Administration has requested the manufacturers of Gadolinium, including Multihance, to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in
patients with:

• acute or chronic severe renal insuffciency
• acute renal insufficiency of any severity due to the hepato-renal syndrome or in the
  perioperative liver transplantation period.
  

In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic
information is essential and not available with non-contrast enhanced magnetic resonance
imaging (MR). NSF may result in fatal or debilitating systemic fibrosis affecting the skin,
muscle and internal organs.

Nephrogenic Systemic Fibrosis (NSF)
The warning, in part contains the following: Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular fitration rate .:30 mL/min/1.73m2) and in patients with acute renal insuffciency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced MRl.

For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium-based contrast agent in order to enhance the contrast agent's elimination. The usefulness of hemodialysis in the prevention ofNSF is unkown. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and the degree of renal function impairment at the time of exposure.

Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents. These reports have not always identified a specific agent. Where a specific agent was identified, the most commonly reported agent was gadodiamide (Omniscan TM), followed by gadopentetate dimeglumine (Magnevist(ß) and gadoversetamide (OptiMAR(ß). NSF has also developed following sequential administrations of gadodiamide with gadobenate dimeglumine (MultiHance(ß) or gadoteridol (ProHance(ß). The number of post-marketing reports is subject to change over time and may not reflect the true proportion of cases associated with any specific gadolinium-based contrast agent.

The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unkown and may vary among the agents. Published reports are limited and predominantly estimate NSF risks with gadodiamide.

If you have been diagnosed with NSF you should speak to an attorney.  For a free case evaluation, fill out the form below: