MRI Gadolinium-based Contrast Dye Label Change Due to Life Threatening Risk

Nearly two years ago, the FDA received a high number of adverse events reports relating to Gadolinium-based (GADO) Contrast Dyes used in MRI testing. Adverse events reports are used to describe incidents in which a user of a drug is injured because of the ingredients in the product. In the case of GADO dye, a high number of users who had kidney dysfunction developed Nephrogenic Systemic Fibrosis (NSF).

On September 9, 2011, the FDA has announced a label change to denote the risk of NSF for users of the dye.  While it’s taken nearly two years for the label to be changed, the hope of the FDA is that people who need MRI’s will be better protected from harm with the new label denoting the risk of NSF on GADO dye products.

NSF is a life threatening, painful and debilitating disease that can slowly progress to death as skin sloughs off the body over time. This skin sloughing, is also known as skin death, much like a burn victim suffering from skin death following a serious burn.  GADO dye products that will have the new label include:

• Ablavar (gadofosveset trisodium)

• Eovist (gadoxetate disodium)

• Magnevist (gadopentetate dimeglumine)

• Multihance (gadobenate dimeglumine)

• Omniscan (gadodiamide),

• Optimark (gadoversetamide injection)

• Prohance (gadoteridol)

Radiologists, nephrologists, and dermatologists have been made aware of the new label change and the risks of NSF that is associated with GADO dye agents for certain users.  People using the agent are at greater risk for developing NSF if they suffer from acute kidney injury or chronic, severe kidney disease at the time they undergo the MRI.

These agents were developed to enhance imaging for physicians so that they may better diagnose medical conditions.

If you are in need of a lawyer, contact Burton Padove at 219-836-2200.