[Nephrogenic systemic fibrosis (NSF)--implications for radiology].
Nephrogenic systemic fibrosis (NSF) is a systemic disease with a 5% mortality which was first described in 1997 and which only occurs in patients with severely impaired renal function (GFR <30 ml/min per 1.73 m(2)) and for which an association with previous administration of several Gd-chelates has been observed. According to retrospective case control studies the odds ratio for a patient with severely impaired renal function to develop NSF was increased by a factor of 22-32 when gadodiamide was administered. At this time there are approximately 250 confirmed cases of NSF of which 177 are associated with the administration of gadodiamide and 78 are associated with gadopentetate dimeglumine. This review article elucidates the postulated pathogenesis of NSF and provides an overview of the published statements and recommendations from international regulatory authorities and from international advisory boards. Even though the pathogenesis is not completely understood at this time, the European Pharmacovigilance Working Party has decided that gadodiamide and gadopentetate dimeglumine must not be used in high-risk patients. Other Gd-containing contrast agents should only be administered after thorough assessment of the indication and with minimized Gd dose. In the USA, the FDA has issued a black box warning for Gd-containing contrast agents.
Michaely
H J
HJ
Institut für Klinische Radiologie, Klinikum Mannheim der Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Deutschland. Henrik.Michaely@rad.ma.uni-heidelberg.de
Thomsen
H S
HS
Reiser
M F
MF
Schoenberg
S O
SO
D016022:Case-Control Studies; D003287:Contrast Media / Q000009:adverse effects*; D005355:Fibrosis / Q000139:chemically induced*; D019786:Gadolinium DTPA / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D051437:Renal Insufficiency / Q000150:complications*; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration
D003287:Contrast Media; C064925:gadodiamide; D019786:Gadolinium DTPA