title: Safety aspects of gadofosveset in clinical practice--analysis of acute and long-term complications.
abstract: OBJECTIVE
  The purpose of this retrospective study was to systematically search for acute adverse reactions and long-term complications in all patients that had been administered gadofosveset at our hospital.
  
  
  METHODS
  We identified 67 gadofosveset administrations during 2006-2009 in 62 patients from 8 to 84years of age. Radiological information system (RIS) and clinical patient records were analyzed for suspected acute adverse reactions and long-term complications including nephrogenic systemic fibrosis (NSF). The gadofosveset doses ranged between 0.024 and 0.060mmol/kg bodyweight with a mean dose of 0.031-mmol/kg bodyweight. Follow-up time of the patients ranged from less than 1year up to 4years with a mean follow-up time of 2.1years.
  
  
  RESULTS
  No acute adverse events or technical failures related to the contrast medium were recorded in the RIS. No dermatological and nephrological diseases related to the gadofosveset administration were found in the clinical patient records. Four patients died during follow-up without any apparent relation to the gadofosveset exposure.
  
  
  CONCLUSIONS
  Based on our clinical material we conclude that gadofosveset is safe for a mixed patient population with no acute adverse events or any indications of long-term complications during the follow-up time up to four years.
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden.
authors.forename: Alaa
authors.initials: A
authors.lastname: Alhadad
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden.
authors.forename: Michael
authors.initials: M
authors.lastname: Akesson
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden; Vascular Center, Skåne University Hospital, S-20502 Malmö
authors.forename: Leena
authors.initials: L
authors.lastname: Lehti
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden; Department of Radiology, Skåne University Hospital, S-20502 Malmö
authors.forename: Peter
authors.initials: P
authors.lastname: Leander
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden; Department of Nephrology and Transplantation, Skåne University Hospital, S-20502 Malmö
authors.forename: Gunnar
authors.initials: G
authors.lastname: Sterner
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Akeson
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Sweden; Vascular Center, Skåne University Hospital, S-20502 Malmö. Electronic address: johan.wasselius@gmail.com.
authors.forename: Johan
authors.initials: J
authors.lastname: Wassélius
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002908:Chronic Disease; D003287:Contrast Media; D005260:Female; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000175:diagnosis*; D009942:Organometallic Compounds / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D005682:Gadolinium; C109932:gadofosveset trisodium
keywords: Blood pool contrast medium; Gadofosveset; Gadolinium based contrast medium; Magnetic resonance imaging; Nephrogenic systemic fibrosis