CardioGen-82 Returning from Recall, But Who's at Fault?

Washington, DCPulled from the market in July of last year, a nuclear perfusion agent is on its way back, according to a March release from States News Service (3/6/12). CardioGen-82 will be making a return appearance to the marketplace accompanied by a black box warning with regard to radiation levels and product administration.

The manufacturer of the perfusion agent, used to evaluate coronary artery disease, undertook a voluntary CardioGen-82 recall last summer after receiving reports that some patients were exposed to more radiation than they otherwise should.

The American Society of Radiologic Technologists announced that Bracco Diagnostics Inc., in tandem with the US Food and Drug Administration (FDA), were restoring CardioGen-82 to the marketplace with beefed-up warnings and cautions.

According to a published report in the Journal of Nuclear Medicine (3/12), the FDA issued a safety announcement on January 12 with regard to ongoing investigations surrounding CardioGen-82 PET. At the time that Bracco recalled CardioGen-82 last July, the FDA stated that while there was minimal risk stemming from the reported exposures; the regulator duly recommended the use of other types of nuclear scans for purposes of cardiac diagnostics until an investigation could be completed.

The FDA has since revealed that the primary culprit associated with the increased exposure related to "improper usage of CardioGen-82 at certain clinical sites, thereby exposing some patients to more radiation than is typically associated with a CardioGen-82 scan," the FDA wrote in January. "This increased radiation exposure was due to the administration of CardioGen-82 generator eluates that contained excessive concentrations of 82Sr and 85Sr." This excessive release of 82Sr and 85Sr in generator eluates is known as "strontium breakthrough." The FDA believed it to be "unlikely that this excessive exposure posed significant risks to patients, though exposure to any excessive radiation is undesirable."

The FDA went on to say that the manufacturer of Bracco imaging was in the throes of assessing clinical sites across the US to determine the reality or potential for higher exposure to radiation. "Preliminary data has shown that, of 375 patients who were surveyed at 43 clinical sites, 54 patients were planned for further radiation testing because of abnormal screening test results," the FDA said. "All 54 patients are from 2 clinical sites. Both sites appear to have insufficient documentation of compliance with the CardioGen-82 labeling recommendations for strontium breakthrough testing."

A communiqué issued by Bracco Diagnostics this past December outlined a number of initiatives supporting an end to the recall, and the return of CardioGen-82 to the market with more robust warnings and user guidelines.

To that end, anyone considering a CardioGen lawsuit would have to determine or speculate if fault lay with the manufacturer or the clinical sites at which the cardiac PET imaging may have been improperly used.

Was radiation over-exposure the fault of the product, the clinic or the manufacturer for not outlining more stringent guidelines from the outset? The controlled and phased reintroduction of CardioGen-82 in concert with the FDA, together with data collection and field use evaluation beginning this year, may be laudable, but may do little to dispel the fears of some patients for whom over-exposure to radiation, no matter how small, remains an ongoing source of fear.