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.
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.
The estimated amount of excess radiation the two patients received is similar to what other patients may receive with cumulative exposure to certain other types of heart scans, FDA said. The FDA said doctors should consider alternative radioactive drugs until the investigation is complete. The agency said patients who have recently had a heart scan should talk to their healthcare professional if they have any questions. The FDA noted that many heart scans don't involve use of CardioGen-82.
CardioGen-82 has been on the U.S. market since 1989. The FDA said the radiation exposure from the product is normally lower than radiation exposure from other types of heart scans.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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