title: [Nephrogenic systemic fibrosis as an adverse drug reaction of gadolinium-based contrast media for magnetic resonance imaging].
abstract: Nephrogenic systemic fibrosis (NSF) was first described as nephrogenic fibrosing dermopathy (NFD), a disease occurring exclusively in patients with severe renal insufficiency. Recently NSF was recognised to be a very rare adverse drug reaction (ADR) of gadolinium-based contrast media for magnetic resonance imaging (MRI). Over 200 million applications of gadolinium-based contrast agents have been performed worldwide, including about 80 million of Magnevist and 33 million of Omniscan. Cases of NSF have been reported so far only for Omniscan (180 including 77 from the EU), for Magnevist (78 including 9 from the EU, 4 of which were also exposed to Omniscan) and for OptiMARK, which is not authorized in the EU. Because of this risk an EU-wide contraindication was ordered for patients with severe renal failure for the use of Omniscan (gadodiamid), which is one of eight gadolinium-based substances authorized in Germany and the EU and which has the highest risk potential, and just recently also for Magnevist (gadopentetate-dimeglumine). Whether similar measures will be implemented for other gadolinium-based substances, for which no cases of NSF have been reported, but a risk potential may exist, is still under discussion.
authors: Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Deutschland. giersig@bfarm.de
authors: C
authors: C
authors: Giersig
mesh_terms: D000075202:Contraindications; D003287:Contrast Media / Q000009:adverse effects*; D005062:European Union; D005355:Fibrosis / Q000139:chemically induced*; D019786:Gadolinium DTPA / Q000009:adverse effects*; D005858:Germany; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D051437:Renal Insufficiency / Q000150:complications*; D012307:Risk Factors; D012871:Skin Diseases / Q000139:chemically induced*
chemical_list: D003287:Contrast Media; C064925:gadodiamide; D019786:Gadolinium DTPA
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