The SonoVue ultrasound contrast agent from Bracco of Milan, Italy, has been reinstated for use in echocardiography applications in Europe by the Commission of the European Communities, the executive body of the European Union. In May, Bracco had suspended the product for European echocardiography use after reports of problems in some heart disease patients who had received the agent.
The reinstatement follows a safety review of SonoVue’s risk-benefit profile and a positive opinion issued by the Committee for Human Medicinal Products (CHMP) in July 2004, according to Bracco. Bracco has added additional contraindications to SonoVue as part of the reinstatement, advising against the agent's use in patients with recent acute coronary syndrome or clinically unstable ischemic heart disease.
SonoVue was suspended for echo applications following reports of severe allergic reactions and heart problems among some heart patients after administration of the product during cardiac ultrasound studies. SonoVue continued to be available for noncardiac applications, such as vascular, breast, and liver use.
SonoVue went on the European market in 2001. The product has not been approved for use in the U.S.
By AuntMinnie.com staff writers
November 1, 2004
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CHMP recommends SonoVue reinstatement, August 5, 2004
Bracco clarifies SonoVue restrictions, May 24, 2004
EMEA restricts use of SonoVue, May 20, 2004
Bracco sets up new facility in Italy, May 4, 2004
Bracco forms Chinese joint venture, April 5, 2004
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