FDA Alert Focuses On Potential Rubidium Overexposure

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The U.S. Food and Drug Administration (FDA) has issued an alert to the medical community and the public in general about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (manufactured by Bracco Diagnostics, Inc. of Milan, Italy). FDA says it has received reports of two patients who had been administered more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes that may have been inadvertently injected into the patients due to a “strontium breakthrough” problem with CardioGen-82, according to the agency.

“At this time, FDA believes that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable,” the warning reads. The agency says the estimated amount of excess radiation received by the two patients is similar to that which “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 reports that is actively investigating the root cause of the situation and will promptly issue updates. In the interim, the agency recommends that health care professionals 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 also urged 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 at www.fda.gov/MedWatch/report.htm; downloading the pre-addressed, postage-paid FDA Form 3500 at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm; calling (800) 332-1088 to request the form), completing it, and faxing it to (800) FDA-0178; or mailing the completed form to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.

For more information, click here: http://www.fda.gov/Drugs/DrugSafety/ucm263112.htm.