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

• Published in: Ultrasound in medicine & biology Vol. 32; no. 9; p. 1369
• Main Authors: Piscaglia, Fabio, Bolondi, Luigi
• Format: Journal Article
• Language: English
• Published: England 01-09-2006
• Subjects: Abdomen - diagnostic imaging; Adverse Drug Reaction Reporting Systems; Contrast Media - adverse effects; Humans; Liver - diagnostic imaging; Phospholipids - adverse effects; Retrospective Studies; Sulfur Hexafluoride - adverse effects; Ultrasonography
• ISSN: 0301-5629
• DOI: 10.1016/j.ultrasmedbio.2006.05.031

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.