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U.K. issues new advice on the use of gadolinium-based contrast agents

(09.05.2019)


Background:
Magnetic resonance imaging (MRI) is an indispensible method for clinical diagnostic used for imaging inner organs. Almost every second MRI examination worldwide is enhanced by application of a Gd-based contrast agent (GBCA). GBCAs are used to enhance the images and allow physicians interpreting the exam to distinguish blood vessels from nearby tissue. Safety claims for the GBCAs are based on the high stability of the agents and the high solubility leading to rapid excretion in an intact state. However, a first safety issue was recognized several years ago, when it was found that fast and complete excretion is hindered among patients with impaired kidney function. Development of adverse health conditions such as nephrogentic systemetic fibrosis (NSF) under conditions of impaired excretion has been reported. Yet, it was previously widely believed that GBCAs are rapidly and completely excreted from the human body in patients with normal kidney function. Yet in 2015 researchers found gadolinium in the brains of humans having received GBCAs before. Since than both the European Medicines Agency (EMA) and the US FDA have issued recommendations for radiologist for the safe administration of GBCAs.


The new guide:

This guidance looks in depth at important issues around the administration of gadolinium-based contrast agents to adult patients, addressing concerns around the potential for long-term gadolinium retention in the brain and the risk of nephrogenic systemic fibrosis.

The authors of the report state that "the potential and theoretical risks of intravenous administration of GBCAs for MRI must be weighed against the potential benefits to the patient".

The guidance also clarifies that "GBCAs are associated with a very low rate of immediate adverse events (0.06%-0.09%), and most adverse events are mild and can be managed in the radiology department". "Major life-threatening contrast reactions to GBCAs are extremely rare. The incidence of acute, severe reactions is estimated to be 0.0025-0.005%."

Yet, "to minimise risk, it is important to identify individuals at an increased risk of an adverse event. Appropriate steps should always be taken to reduce the risk of contrast reactions."

The guidance provides eight key recommendations to support practitioners using gadolinium-based contrast agents in the treatment of their patients and covers safety, prescribing, consent, identification of patients at increased risk from contrast administration, and pregnancy and lactation.

The key recommendations are as follows:
  1. An individual trained in recognizing and treating severe contrast reactions, including anaphylaxis, should be immediately available for the department where intravenous contrast is administered.
  2. A formal record of the decision to inject contrast should be made before administration.
  3. The individual administering the contrast must check that there are no contraindications to its use and ensure that the patient understands that it is to be given and agrees to the procedure.
  4. In cases where there is a previously reported moderately severe or severe reaction to contrast, caution should be exercised and the need for contrast should be re-examined with respect to an unenhanced study or other potential methods of investigation.
  5. For elective examinations in patients who have a history of previous contrast reactions, referral to a specialist drug allergy service should be considered for assessment and testing against a panel of contrast compounds to determine the safety of administration.
  6. The dose of GBCA should be minimized, taking into consideration the indication, the patient's body weight, and the information from the manufacturer contained in the summary of product characteristics. The dose administered should be recorded electronically for audit purposes.
  7. When using GBCAs, knowledge of the patient's renal functional status is generally advisable. GBCAs should be used with caution in patients with severe chronic or acute renal impairment, in patients in the perioperative liver transplantation period, and in neonates.
  8. Significant suspected contrast reactions should be formally documented with full details, investigated appropriately with advice given to the patient, and referral made to a specialist drug allergy service to help guide future management.

This guidance replaces the previous guidance on Gadolinium-based contrast media and nephrogenic systemic fibrosis and Standards for intravascular contrast administration in adult patients, third edition, which have now been archived.



The cited guide:



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last time modified: May 9, 2019



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