Following a recent European review, the summaries of product characteristics for gadolinium-containing products are to be updated and harmonised, so that the information is the same throughout the EU.
Nephrogenic systemic fibrosis (NSF) can be a very serious and life-threatening condition. NSF is characterised by formation of connective tissues in the internal organs as well as the skin, which thickens and becomes hard and coarse. NSF is only seen in patients with renal impairment who have been examined with a gadolinium-containing MRI contrast agent.
Three NSF risk groups
Since 2007, the EU member states have agreed on classifying gadolinium-containing contrast agents into three NSF risk groups – based on information on the contrast agents' physicochemical properties as well as the number of reported NSF cases associated with each individual product:
(gadoxetic acid) NB not marketed in Denmark
|Magnevist® (gadopentetic acid)
In the latest EU review, focus has been on the risk of NSF in patients with renal impairment, in patients who are undergoing a liver transplant, in newborns, infants and the elderly as well as in pregnant or breastfeeding women.
In addition, the need for screening for kidney problems and the need for dose restrictions have been considered. Furthermore, precautions have been determined to ensure that the contrast agent used in each individual patient is registered correctly. Finally, the need for additional studies has been assessed.
Please see the updated recommendations from the European Medicines Agency (EMA) in the factbox to the right.
A working party under the Danish National Board of Health is currently revising the Danish instructions for use of contrast agents, so they include the new recommendations. Please see the most recent Danish instructions from September 2009 in the factbox to the right.
The Danish Medicines Agency advises doctors and patients to report any possible side effects.