Ultrasound in Medicine and Biology
Volume 32, Issue 9 , Pages 1369-1375, September 2006

The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations

  • Fabio Piscaglia

      Affiliations

    • Corresponding Author InformationAddress correspondence to: Fabio Piscaglia, Div. of Internal Medicine, Via Albertoni 15, 40138 Bologna, Italy.
    • ,
  • Luigi Bolondi
    • ,
  • Italian Society for Ultrasound in Medicine and Biology (SIUMB) Study Group on Ultrasound Contrast Agents1

      Affiliations

    • L. Aiani, M. Luigi Angeli, V. Arienti, L. Barozzi, R. Basilico, M. Bertolotto, E. Biasini, P. Busilacchi, F. Calliada,* M. Caremani, E. Caturelli, N. Celli, A. Colecchia, L. Cova, M. Assunta Cova, L. Crocetti, I. de Sio, F. Drudi, G. Ferraioli, C. Filice, F. Fornari, S. Gaiani, F. Giangregorio, A. Giorgio, T. Ierace, R. Lencioni, T. Livraghi, F. Magnolfi, A. Martegani, F. Meloni, G. Menozzi, G. Pelosi, M. Pompili, L. Riccardi, P. Ricci, L. Rubaltelli, D. Sacerdoti, G. Serafini, C. Serra, L. Solbiati, D. Tacconi, M. Valentino, G. Vidili and F. Vitali

Division of Internal Medicine, Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy

Received 28 February 2006; received in revised form 17 May 2006; accepted 23 May 2006.

Abstract 

The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents. (E-mail: Piscagl@med.unibo.it)

Key Words:  Adverse effect , Contrast agents , Contrast-enhanced ultrasonography , Ultrasound

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PII: S0301-5629(06)01643-7

doi:10.1016/j.ultrasmedbio.2006.05.031

Ultrasound in Medicine and Biology
Volume 32, Issue 9 , Pages 1369-1375, September 2006

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