Diagnostics Xagena
The FDA ( Food and Drug Administration ) has notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography ( PET ) scans with Rubidium-82 chloride injection from CardioGen-82.
FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to Strontium isotopes which may have been inadvertently injected into the patients due to a strontium breakthrough problem with CardioGen-82.
FDA believes that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable. The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans. It would take much more radiation to cause any severe adverse health effects in patients.
Healthcare professionals should closely follow the required testing and quality control procedures essential to help detect Strontium breakthrough from CardioGen-82.
Other types of heart scans provide information very similar to CardioGen-82 and professionals are encouraged to consider these alternatives while FDA completes its investigation of the reported cases of excess radiation exposure.
Source: FDA, 2011
XagenaMedicine_2011
