FDA Update on Ongoing CardioGen-82 Investigations

January 13, 2012

FDA Update on Ongoing CardioGen-82 Investigations

On January 12, 2012, The U.S. Food and Drug Administration (FDA) updated the public and healthcare professionals about preliminary findings from the ongoing investigations following Bracco Diagnostics, Inc. voluntary recall of CardioGen-82 on July, 25, 2011.

Multiple investigations from preliminary information, suggests that improper usage of CaridGen-82 at certain clinical sites is responsible for the exposure of patients to more radiation than is normally associated with a CardioGen-82 scan. The increased radiation exposure was due to the administration of CardioGen-82 generator eluates that contained excessive concentrations of strontium-82(SSR-82) and strontium-85(Sr-85), also known as “Strontium breakthrough.” The FDA announced that it is very unlikely that this caused major risks to patients.

Bracco Diagnostics, Inc. are conducting studies at clinical sites to evaluate and assess the amount to which patients have been exposed to excessive radiation. Out of 375 patients surveyed at 43 clinical sites, 54 patients were found to have abnormal screening test results. All 54 patients are from two clinical sites, which appear to have insufficient documentation of compliance with CardioGen-82 labeling recommendations for strontium breakthrough testing.

The SNM will continue to keep you updated on the ongoing investigations.  

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