FDA Puts Stop to Use of CardioGen-82, Voluntary Recall Initiated

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In a follow-up to an advisory issued on July 15, the U.S. Food and Drug Administration (FDA) has alerted health care professionals to stop using CardioGen-82 for cardiac PET scans.

Voluntarily recalled by its manufacturer, Bracco Diagnostics, Inc., in response to the FDA’s latest alert, CardioGen-82 consists of a generator used at clinical sites to produce rubidium (Rb)-82 chloride injection. In the initial advisory, the FDA advised the health care community and the general public about the possibility of inadvertent, increased radiation exposure in patients who had undergone or would be undergoing cardiac PET scans with Rb-82 chloride injection from CardioGen-82. At that time, the agency noted that it had received reports of two patients who received more radiation than expected as a result of CardioGen-82 usage.

“The FDA believes that the risk of harm from this exposure is minimal, though exposure to any excessive radiation is undesirable,” the July 15 advisory reads. “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.”

Nonetheless, further investigation by the FDA revealed that current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection and, in turn, help to avert strontium breakthrough. The agency is currently investigating the sufficiency of the testing procedures used to detect strontium breakthrough at clinical sites that use CardioGen-82.

Moreover, FDA continues to work with Bracco Diagnostics and the Nuclear Regulatory Commission to determine the root cause for the increased radiation exposure detected in the two patients. The extent to which any additional patients may have received inadvertent radiation exposure is under investigation as well.