Update on NSF
A horrible adverse reaction
Have you met a patient with NSF?
History
Severe cases (grade 3 – 4)
EMEA uses 3 classes – FDA 1 class.
The magnitude of the problem is unclear
Yale university (NSF registry)
NSF publications / Pubmed
In the peer-reviewed literature (biopsy proven) 190
Biopsy-proven cases in the peer-reviewed literature
According to Hill’s criteria:
Europe
The EU database has only 8 Swiss cases.
There is an uneven distribution of original reports/ case reports in the peer-reviewed literature:
We have a reporting problem in Europe.
FDA ~600 cases
Some hospitals are now reporting that they have reviewed their nephrology patients.
Most studies are derive from search on databases e.g.
Prevalence in clinically inspected CKD 5 patients
Is something left over?
In biopsies (several patients had more than one biopsy) an increasing amount of gadolinium has been shown in the skin up to three years after the last exposure to Gd-CA.
There are reports that NSF may develop several months and years after administration of Gd-CA.
Gd accumulates in bones of humans with normal renal function.
Gd accumulates in skin and bone of rodents with normal renal function.
It is well known that heavy metals accumulate in the bone in man.
Will we face a major health problem in the future?
High risk patients could be
Contentious subject
2002-2008
2002-2007
Erythropoietin
Gadodiamide + Magnevist + Optimark
Slide 35
The risk of inducing NSF must always be weighed against the risk of denying patients gadolinium enhanced scans which are important for patient management.
We don’t have an appropriate overview of the problem, including pathophysiology.
Slide 38