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FDA warns against using PET scan agent
The FDA has issued a warning to healthcare professionals telling them to stop using CardioGen-82 due to the potential for increased radiation exposure in patients who undergo PET scans.
The agent, manufactured by Bracco Diagnostics, utilizes the radioactive drug rubidium-82 chloride injection. According to the FDA release, the agency has received reports that two patients received more radiation than expected from CardioGen-82, which was due to strontium isotopes that may have been inadvertently injected into the patients resulting from a “strontium breakthrough” problem with CardioGen-82.
Although believing the risk to humans to be minimal, the agency viewed any unnecessary exposure to radiation — which was estimated to be similar to what patients may receive with cumulative exposure to other scans — to be undesirable.
Full details of the warning as well as recommendations for physicians currently using the agent can be viewed here.
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