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Ultrasound Med Biol. 2006 Sep;32(9):1369-75.

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations.

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1
Division of Internal Medicine, Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy. Piscagl@med.unibo.it

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.

[Indexed for MEDLINE]

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