In February 2007, the Danish Medicines Agency changed its recommendations concerning the use of Omniscan for kidney patients due to a strong suspicion that the contrast medium may cause the serious adverse reaction: Nephrogenic Systemic Fibrosis.
The change followed shortly after an adverse reaction report from Herlev Hospital in 2006 concerning 20 severe instances of adverse reactions. This led to a thorough investigation under the auspices of the EU, which paved the way for a common European assessment and a change of the recommendations in 2007.
To begin with, the adverse reaction reports in Denmark almost solely concerned kidney patients treated at Herlev Hospital. After a review of the patient records at the hospital Skejby Sygehus, it has emerged that at least 10 more patients suffer from similar adverse reactions. The new cases have developed in the same way as they did at Herlev Hospital, and therefore they do not give rise to further tightening of the 2007 recommendations or changes to the summary of product characteristics.
After the recommendations were published in 2007, the use of the substance has decreased significantly, and since April 2008 it has practically not been used.