The use of micro-bubble contrast agent for echocardiography declined 22 percent in the 2008 second quarter, compared to usage just two years earlier, according to research form Arlington Medical Resources (AMR), a provider of market information for the pharmaceutical and diagnostic imaging industries.
In October 2007, the FDA placed a black-box warning on ultrasound micro-bubble contrast agents after 10 deaths were reported following administration. Overall, reports of 190 serious but non-fatal reactions were also documented.
“The effects of the black-box warnings in 2007 are still being felt in the micro-bubble contrast agent market," said Anna Fisher, analyst at AMR. "Even after the FDA revised its warning in May 2008 allowing the agents to be used more broadly, usage still declined in the second quarter of 2008. The role of ultrasound contrast agents continues to be important in the overall echocardiography market because it enhances imaging quality for interpretation.”
The current edition of the U.S. Echocardiography Monthly Monitor also found that the total number of patients undergoing echocardiographies in the United States had declined by 17,095 in June. The total number of patients undergoing contrast-enhanced echocardiography for the U.S. market also has declined slightly by 2,137.