Drug Safety and Availability > FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans

The U.S. Food and Drug Administration (FDA) is alerting the public; in particular, 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 (Rb)-82 chloride injection from CardioGen-82 (manufactured by Bracco Diagnostics, Inc.). A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart.

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.

At this time, 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.

FDA is actively investigating the root cause of this failure with CardioGen-82 and will promptly notify the public with updates.

For more information, please visit: Cardio-Gen-82 ►
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