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Table 3 The FDA guidelines from 2006, 2007 and 2010 (www.fda.org)

From: Minimizing Risk of Nephrogenic systemic fibrosis in Cardiovascular Magnetic Resonance

FDA 2006

FDA 2007

FDA 2010

 

Boxed Warning for GBCAs

Change in labeling for GBCAs

Patients at risk:

Patients at risk:

Patients at risk:

Moderate to end stage kidney disease (GFR < 60 ml/min/1.73 m²)

Acute or chronic severe renal insufficiency (GFR < 30 ml/min/1.73 m²)

Acute renal insufficiency due to hepatorenal syndrome or in the perioperative phase of a liver transplant

Highest risk for patients with GFR < 30 ml/min/1.73 m²

Repeated or high dosage GBCA enhanced procedures

NO RISK: patients with normal kidney function

 

Screen all patients for renal dysfunction (history and/or lab tests)

Screen all patients for renal dysfunction (history for assessment of acute kidney failure, lab tests for patients at risk for chronic renal failure) Risk factors are Diabetes, Hypertension, heart disease, smoking, obesity, high cholesterol, family history of kidney disease, age 65 or older, urinary tract infections/obstructions, systemic infections or autoimmune diseases [91]

Measures:

Measures:

Measures:

Carefully weigh pros and cons of GBCA enhanced imaging

avoid GBCA unless absolutely necessary

Gadodiamide, Gadoversetamid, Gadopentet Acid are contraindicated for highest risk patients

Use alternative imaging if possible

do not exceed recommended dose

take the elimination half life into account and allow enough time for GBCA elimination before rescanning the patient

Avoid GBCAs in patients with impaired (known/suspected) drug elimination unless absolutely necessary

Consider prompt dialysis in all patients with impaired renal function

Consider prompt dialysis in patients that are already on dialysis treatment

Consider prompt dialysis in patients that are already on dialysis treatment

  

Monitor patients after GBCA administration, good documentation, no repeat GBCA imaging procedures until GBCA is eliminated from the body