The FDA has warned about the potential for excess radiation exposure in patients who underwent heart scans involving a radioactive drug called CardioGen-82.
Bracco Diagnostics Inc. is the maker of this drug. It has been is used in some positron emission tomography, or PET, scans involving the heart in order to diagnose heart disease. Bracco Diagnostics is part of Bracco SPA, a private firm based in Milan, Italy. A company spokeswoman said the firm was working with FDA and other regulatory authorities to investigate the problem.
The agency said it recently became aware of two patients who underwent PET imaging scans with CardioGen-82 and were later found to have detectable levels of radiation several months after their PET scans. Both patients were crossing the border to or from the United States when radiation detectors identified radiation originating from them.
The FDA said it believes "that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable." The total number of patients who might have been exposed to excess radiation is currently unknown, but the FDA said the investigation into the problem is continuing.