Radiology FDA Drug Safety Communication

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.

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.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by:

* Completing and submitting the adverse report online: www.fda.gov/MedWatch/report.htm

* Downloading the pre-addressed, postage-paid FDA Form 3500 a href="http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm">http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm> (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or

* Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

More information is available on FDA's website at http://www.fda.gov/Drugs/DrugSafety/ucm263112.htm.