Safety aspects of gadofosveset in clinical practice--analysis of acute and long-term complications

Magn Reson Imaging. 2014 Jun;32(5):570-3. doi: 10.1016/j.mri.2014.02.012. Epub 2014 Feb 13.

Abstract

Purpose: 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.

Materials and 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.

Keywords: Blood pool contrast medium; Gadofosveset; Gadolinium based contrast medium; Magnetic resonance imaging; Nephrogenic systemic fibrosis.

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Child
  • Chronic Disease
  • Contrast Media
  • Female
  • Gadolinium / adverse effects*
  • Humans
  • Magnetic Resonance Imaging / adverse effects
  • Male
  • Middle Aged
  • Nephrogenic Fibrosing Dermopathy / chemically induced*
  • Nephrogenic Fibrosing Dermopathy / diagnosis*
  • Organometallic Compounds / adverse effects*
  • Retrospective Studies
  • Risk Assessment
  • Young Adult

Substances

  • Contrast Media
  • Organometallic Compounds
  • Gadolinium
  • gadofosveset trisodium