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

Fabio Piscaglia, Luigi Bolondi, 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. DrudiG. 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, F. Vitali

Research output: Contribution to journalArticle

400 Scopus citations

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).

Original languageEnglish (US)
Pages (from-to)1369-1375
Number of pages7
JournalUltrasound in Medicine and Biology
Volume32
Issue number9
DOIs
StatePublished - Sep 1 2006

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Keywords

  • Adverse effect
  • Contrast agents
  • Contrast-enhanced ultrasonography
  • Ultrasound

ASJC Scopus subject areas

  • Biophysics
  • Radiological and Ultrasound Technology
  • Acoustics and Ultrasonics

Cite this

Piscaglia, F., Bolondi, L., Aiani, L., Luigi Angeli, M., Arienti, V., Barozzi, L., Basilico, R., Bertolotto, M., Biasini, E., Busilacchi, P., Calliada, F., Caremani, M., Caturelli, E., Celli, N., Colecchia, A., Cova, L., Assunta Cova, M., Crocetti, L., de Sio, I., ... Vitali, F. (2006). The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations. Ultrasound in Medicine and Biology, 32(9), 1369-1375. https://doi.org/10.1016/j.ultrasmedbio.2006.05.031