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

A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Magnetic Resonance Imaging (MRI) | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
BGN Technologies Introduces Novel Medical Imaging Radioisotope Production Method
News | Radiopharmaceuticals and Tracers | June 05, 2019
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for...
RefleXion Opens New Manufacturing Facility for Biology-guided Radiotherapy Platform
News | Radiation Therapy | May 31, 2019
RefleXion Medical recently announced the opening of its new manufacturing facility at its headquarters in Hayward,...
Study Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI

Image courtesy of MR Solutions.

News | PET-MRI | May 23, 2019
Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Blue Earth Diagnostics Expands Access to Axumin in Europe
News | Radiopharmaceuticals and Tracers | May 13, 2019
Blue Earth Diagnostics announced expanded access to the Axumin (fluciclovine (18F)) imaging agent in Europe. The first...
Shine Medical Technologies Breaks Ground on U.S. Medical Isotope Production Facility

Image courtesy of Amen Clinics

News | Radiopharmaceuticals and Tracers | May 10, 2019 | Jeff Zagoudis, Associate Editor
Shine Medical Technologies Inc. broke ground on their first medical isotope production facility in Janesville, Wis. U.S...
A 3-D printed tungsten X-ray system collimator. 3D printed, additive manufacturing for medical imaging.

A 3-D printed tungsten X-ray system collimator. The tungsten alloy powder is printed into the form desired and is laser fused so it can be machined and finished. Previously, making collimators from Tungsten was labor intensive because it required working with sheets of the metal to create the collimator matrix. 

Feature | Medical 3-D Printing | April 29, 2019 | By Steve Jeffery
In ...
NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve