Italian contrast developer Bracco of Milan sought to clarify several points related to regulatory restrictions placed on its SonoVue ultrasound contrast agent by the European Agency for the Evaluation of Medicinal Products (EMEA).
The EMEA last week announced that it was restricting the use of SonoVue for echocardiography applications after receiving reports of allergic reactions that had resulted in the deaths of several patients.
In a follow-up to the EMEA announcement, Bracco noted that the restriction was temporary, taken as a precautionary measure while the company works with regulatory authorities to identify "risk/benefit balance of the product in echocardiography," the company said. Bracco has a meeting scheduled with the EMEA to discuss the issue.
Bracco also said that the number of fatalities -- three patients -- that occurred after SonoVue use meant that such occurrences were rare, and that the product has had a 0.017% adverse-event rate in the 168,000 procedures conducted since it was approved for European use in 2001. Finally, Bracco said that the fatalities occurred in patients who already had pre-existing severe coronary artery disease.
SonoVue remains available for non-echocardiography applications, such as vascular and oncology imaging. The product is not currently available in the U.S.
By AuntMinnie.com staff writersMay 24, 2004
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