FDA Advisory on Gadolinium contrast agents

The FDA has an updated Public Health Advisory on the safety of gadolinium-based MRI contrast agents. In a nutshell, patients with any sort of renal disease or otherwise compromised kidney function are at high risk of developing Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) if they receive gadolinium contrast agents for MRI imaging. There seems to be no risk for patients without compromised kidney function.

The initial cases were observed with Omniscan, which is the GE product. A Berlex rep claimed to me that their tests show that Magnevist is less susceptible (in their own testing, on rats, so…) because the chelation of the gadolinium is stronger. The FDA advisory extends to all gadolinium agents however (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance) and any claim by one manufacturer or another about the relative safety of their product with regards to NSF/NFD should be considered highly suspect.

Note that these contrast agents were never approved for MRA studies to begin with, so there’s always been some risk involved. By no means though should anyone take this issue to mean that contrast agents in MRI are unsafe for general use. The diagnostic benefits of contrast still outweigh the risk for the vast majority of patients. More information directed specifically to healthcare providers has also been made available by the FDA (PDF link).

Part of our goal at Reference Scan is to provide a resource where concerned laypeople can interact with informed professionals in the field. So if you’re coming here on a google search or otherwise, and have more questions, feel free to ask in the comment thread, and we will do our best to answer.

At any rate, the updated FDA health advisory has all the latest details, the verifiable ones anyway.

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