FDA Flags Incidents of Excess Radiation Exposure to Patients

Regulatory NewsRegulatory News | 29 April 2019 |  By 

The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans.

The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high levels of radiation due to incorrect solutions to elute the generators. The new boxed warning will address this user error as a reminder to use correct solutions.

Bracco Diagnostics’ CardioGen-82 and Jubilant DraxImage’s Ruby-Fill are the two systems that require additive-free 0.9% sodium chloride injection USP.

“Incidents have been reported to FDA where an incorrect solution was used to elute the generator, including calcium-containing solutions such as lactated ringers. The calcium in the solution interacts with radioactive strontium 82 and strontium 85 in the generator’s structure. These radioisotopes of strontium then ‘break through’ into the rubidium injection administered to patients,” FDA said. “The strontium isotopes can deposit high levels of radioactivity in organs including the bone, which can lead to suppressed bone marrow function and suppression of the immune system. Additional long-term risks could include radiation-induced cancers.”

The agency clarified that patients who need myocardial perfusion imaging scans should continue getting such scans and consult with their health care providers on concerns with using rubidium 82 generators.

Both manufacturers are going to conduct testing to evaluate the risks posed by the strontium isotopes.



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