Published: September 2011

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Gadolinium based contrast agents and Nephrogenic Systemic Fibrosis

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Prescriber Update 32(3): 22-23
September 2011

Prescribers are reminded of a rare but severe side effect associated with gadolinium based contrast agents, often used during MRI. This reminder follows a recent publication that describes five cases of Nephrogenic Systemic Fibrosis (NSF) associated with the use of Omniscan (gadodiamide) in New Zealand.1

A review by the European Medicines Agency in 2010 concluded that GBCAs are associated with varying degrees of risk of developing NSF.3 This difference appears to be related to their ability to release free gadolinium ions into the circulation.

Using the European classification, the GBCAs approved for use in New Zealand can be placed in the following risk categories:

  • High risk: Omniscan (gadodiamide), Magnevist (gadopentetic acid)
  • Medium risk: Multihance (gadobenic acid)
  • Low risk: Gadovist (gadobutrol), Dotarem (gadoteric acid)

NSF is a very rare systemic disease characterised by thickening and hardening of the skin with fibrosis of the dermis.2 It can also affect other organs such as the lungs and the heart.

NSF presents with pain, pruritis, joint stiffness, tightness, swelling of the hands and feet, paraesthesias and burning.2 Dry skin, weakness and warmth can also occur. Skin findings can be localised or generalised and the distribution is often symmetric and bilateral.

Although the progression of NSF can be unpredictable, all patients eventually develop limitation of movement.2 In some cases the disease is fatal. Although a number of treatments have been proposed, there is currently no single effective treatment for NSF.

Key advice for healthcare professionals:

  • All patients should be screened for renal dysfunction prior to receiving a GBCA.
  • Omniscan and Magnevist are contraindicated for use in patients with severe renal insufficiency (GFR < 30mL/min/1.73m²).
  • Omnisan and Magnevist are contraindicated for use in patients with acute renal insufficiency of any severity due to the hepato-renal syndrome, or in the perioperative liver transplantation period.
  • GBCAs, other than Omniscan and Magnevist, should be used with caution in patients with severe renal insufficiency. However, the minimum recommended dose should be used and sufficient time should be allowed between doses to ensure complete elimination.


Product data sheets for GBCAs are available at: http://medsafe.govt.nz/Medicines/infoSearch.asp

References
  1. Kendrick-Jones J C et al .2011. Nephrogenic systemic fibrosis, in patients with end-stage kidney disease on dialysis, in the greater Auckland region, from 2000-2006. Nephrology 16:
  2. Chen A Y-Y et al .2010. Nephrogenic Systemic Fibrosis: A review. Journal of Drugs in Dermatology 9(7): 829-834.
  3. European Medicines Agency .2010. Questions and answers 243-248. on the review of gadolinium-containing contrast agents. Available at http://www.ema.europa.eu/docs/en_GB/ document_library/Referrals_document/gadolinium_31/ WC500015635.pdf

 

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