MONDAY, July 18 (HealthDay News) -- The U.S. Food and Drug Administration warned health care providers and patients of an increased risk of radiation exposure associated with Bracco Diagnostics Inc.'s cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82.
The CardioGen-82 PET scan is a nuclear medicine scan that uses a radioactive drug, Rb-82 chloride injection, to assess the heart. The FDA issued the warning based on reports of two patients who received more radiation than expected from CardioGen-82, likely due to inadvertent injection of strontium isotopes to address a "strontium breakthrough" problem. Both patients had detectable levels of radiation several months after the PET scans.
According to the FDA, the radiation exposure that the two patients received due to strontium isotope exposure was substantially higher than that typically associated with CardioGen-82. However, the FDA believes that the risk of harm associated with this exposure appears to be minimal, with much higher amounts of radiation exposure needed to cause any severe adverse health effects. The agency is currently investigating the exact cause of the issue associated with the CardioGen-82 and will continue to update health care providers and patients.
According to the FDA, "health care 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."
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