Two patients still irradiated months after medical scans
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 the scans had been performed 2 and 4 months earlier.
FDA Investigating Exposure To Excess Radiation From Certain Heart Scans, WSJ, By Jennifer Corbett Dooren, WASHINGTON (Dow Jones) 16 July 11–-The Food and Drug Administration Friday warned about the potential for excess radiation exposure in patients who underwent heart scans involving a radioactive drug called CardioGen-82.
The product is made by Bracco Diagnostics Inc. and 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 the scans had been performed 2 and 4 months earlier.
The agency said the excess radiation is from strontium isotopes which may have been inadvertently injected into the patients due to a “strontium breakthrough” problem with CardioGen-82. Strontium is used to generate the active ingredient in CardioGen-82, rubidium…..
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