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FDA: Improper use of imaging generator a likely cause of excess radiation exposure
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The FDA is updating health care professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer.
In July 2011, the FDA notified health care professionals to stop using CardioGen-82 (Bracco Diagnostics) for cardiac positron emission tomography (PET) scans and the manufacturer subsequently issued a voluntary recall. Risks were related to the potential for inadvertent increased radiation exposure in patients who underwent or were scheduled for cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82.
An updated safety communication issued by the FDA in January suggested that improper usage of CardioGen-82 at certain clinical sites was responsible for the excess radiation exposure. This increased exposure was due to the administration of CardioGen-82 generator eluates that contained excessive concentrations of strontium-82 (Sr-82) and strontium-85 (Sr-85), also known as strontium breakthrough, according to an agency release.
Bracco Diagnostics is currently conducting studies of clinical sites across the nation to help assess the extent to which patients may have been exposed to excessive radiation. Preliminary data show that, of 375 patients surveyed at 43 clinical sites, 54 patients from two clinical sites were planned for further radiation testing because of abnormal screening test results.
The FDA will continue to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites and to revise the CardioGen-82 labeling to better describe how to use the generator and to implement a plan for the return of CardioGen-82 to the market. Updates will be released when additional information becomes available.