FDA alerts public to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans due to potential for increased radiation exposure

July 26, 2011

FDA alerts public to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans due to potential for increased radiation exposure

On July 26, 2011, The U.S. Food and Drug Administration (FDA) alerted the medical imaging community to stop using CardioGen-82. A CardioGen-82 PET scan is one of many nuclear medicine scans that use radioactive drugs to evaluate the heart.

Two patients were recently reported to have received more radiation then expected of CardioGen-82 due to strontium isotopes which may have been inadvertently injected due to a “strontium breakthrough” problem with CardioGen-82. As a percaution, the manufacturer, Bracco Diagnostics Inc. has decided to voluntarily recall CardioGen-82 and has asked patients to immediately stop using it.

To review more information on this issue, go to FDA’s website at http://www.fda.gov/Drugs/DrugSafety/ucm265278.htm.