News | January 13, 2012

FDA Releases Preliminary Findings From Ongoing CardioGen-82 Investigations

January 13, 2012 – The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 last July by the manufacturer, Bracco Diagnostics. CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection. A CardioGen-82 positron emission tomography (PET) scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate myocardial perfusion.

The preliminary information from the investigations suggests that improper usage of CardioGen-82 at certain clinical sites is responsible for the exposure of some patients to more radiation than is typically associated with a CardioGen-82 scan. This increased radiation exposure was due to the administration of CardioGen-82 generator eluates that contained excessive concentrations of strontium-82 (Sr-82) and strontium-85 (Sr-85). This excessive release of Sr-82 and Sr-85 in generator eluates is known as "strontium breakthrough." FDA believes it is unlikely that this excessive exposure posed significant risks to patients, though exposure to any excessive radiation is undesirable.

In its July 26, 2011 Drug Safety Communication, the FDA said it indentified deficiencies with the manufacturing procedures for CardioGen-82. To date, these deficiencies do not appear to have been related to the excessive radiation exposure detected in some patients. The recalled CardioGen-82 generators that were functional following shipping were tested by the manufacturer to identify potential structural or functional causes of strontium breakthrough. None of the tested generators showed signs of breakthrough. The FDA said it continues to work with the manufacturer to resolve their manufacturing deficiencies.

Bracco is currently conducting studies of clinical sites across the nation to help assess the extent to which patients may have been exposed to excessive radiation. Participation in this study is voluntary and the preliminary data show 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. All 54 patients are from two clinical sites. Both sites appear to have insufficient documentation of compliance with the CardioGen-82 labeling recommendations for strontium breakthrough testing.

The FDA continues to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites. FDA is also working with the manufacturer to revise the CardioGen-82 labeling to better describe how to use the generator and to implement a plan for the return of CardioGen-82 to the market. FDA will update the public when additional information becomes available.

For more information: www.cardiogen.com, www.nrc.gov

Related Content

News | Business | September 19, 2017
September 19, 2017 — Invicro LLC, a provider of imaging services and software for research and drug development, anno
ScImage and Invia Partnership Announced
News | PACS | September 19, 2017
ScImage Inc. and Invia Imaging Solutions recently announced formation of a joint partnership at the American Society of...
Toshiba Highlights Latest CT Advancements at RSNA 2017
News | Computed Tomography (CT) | September 18, 2017
Toshiba Medical announced that it will display several new enhancements to its existing computed tomography (CT)...
Philips Launches CardioMD IV Cardiac SPECT Solution at ASNC 2017
Technology | SPECT Imaging | September 15, 2017
September 15, 2017 — Philips highlighted its newest solution for...
Double Targeting Ligands to Identify and Treat Prostate Cancer

The mice were imaged with small-animal PET/CT using 124I-RPS-027 (7.4 MBq [200 μCi]). Credit: JM Kelly et al., Department of Radiology, Weill Cornell Medicine, New York, NY

News | Prostate Cancer | September 14, 2017
Researchers have demonstrated a new, effective way to precisely identify and localize prostate cancer tumors while...
Blue Earth Diagnostics Announcing Results of FALCON PET/CT Trial at ASTRO 2017
News | PET-CT | September 13, 2017
September 13, 2017 — Blue Earth Diagnostics announced the upcoming oral presentation of initial results from the FALC
FDG-PET/CT Predicts Melanoma Patients' Response to Immune Checkpoint Inhibitor Therapy
News | PET-CT | September 07, 2017
September 7, 2017 — Advanced melanoma has a poor prognosis, but immune checkpoint inhibitor therapy can be effective
German Team Optimizing Therapy Planning for Cancers of the Liver
News | Interventional Radiology | August 29, 2017
Radioembolization is a therapy method used for liver tumors that are uncurable with surgery or chemotherapy. Thorough...
Sponsored Content | Videos | Nuclear Imaging | August 24, 2017
Prem Soman, M.D., director of nuclear cardiology at the Heart and Vascular Institute, University of Pittsburgh, and p
Overlay Init