The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations.
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.
Piscaglia
Fabio
F
Division of Internal Medicine, Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy. Piscagl@med.unibo.it
Bolondi
Luigi
L
D000005:Abdomen / Q000000981:diagnostic imaging*; D016907:Adverse Drug Reaction Reporting Systems; D003287:Contrast Media / Q000009:adverse effects*; D006801:Humans; D008099:Liver / Q000000981:diagnostic imaging; D010743:Phospholipids / Q000009:adverse effects*; D012189:Retrospective Studies; D013459:Sulfur Hexafluoride / Q000009:adverse effects*; D014463:Ultrasonography
D003287:Contrast Media; D010743:Phospholipids; C420843:contrast agent BR1; D013459:Sulfur Hexafluoride