Recent incidents due to use of incorrect solutions resulted in excess radiation exposure to patients
[4/29/2019] FDA is aware of recent incidents that caused excess radiation exposure to patients due to user error with certain systems used to produce rubidium Rb 82 injection for use with Positron Emission Tomography (PET) myocardial (heart) perfusion imaging scans. As a result, the agency is requiring Safety Labeling Changes, including a Boxed Warning, on the labels of rubidium 82 generators, reminding systems users to use the correct solution to elute the generator (solution to extract Rubidium 82 from the generator) and carefully follow safety procedures for the system.
The two systems used in these imaging scans, CardioGen-82 and Ruby-Fill (rubidium Rb 82 generator) require additive- free 0.9% Sodium Chloride Injection USP to safely elute the system. 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. 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.
FDA urges patients who need these imaging scans to continue to get them. Patients should talk to their health care providers about any concerns about use of these systems.
The labels for rubidium 82 generators include instructions about proper use of the systems and warnings about the serious consequences of improper use. Mandatory training is also required for all imaging facilities that use CardioGen-82 and Ruby-Fill systems. Because of the potential for serious adverse events with these errors, FDA has elevated the warnings about improper use in the labeling.
FDA is reminding imaging facility users to always follow these safety procedures when using rubidium 82 generators:
- Use only additive- free 0.9% Sodium Chloride Injection USP to elute a rubidium 82 generator. Strictly adhere to the mandatory eluate testing protocol.
- Immediately stop the patient infusion and permanently discontinue the use of the affected rubidium 82 generator if any solution other than additive- free 0.9% Sodium Chloride Injection USP is used for elution.
- If a patient is administered rubidium 82 injection prepared with the incorrect eluent, evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as the bone marrow.
FDA takes drug safety issues very seriously and will continue to work with the manufacturers to mitigate errors associated with the use of rubidium 82 generators. CardioGen-82’s manufacturer, Bracco Diagnostics Inc, and Ruby-Fill’s manufacturer, Jubilant DraxImage Inc., have distributed and posted Dear Healthcare Provider Letters on their websites to remind imaging centers and clinicians of the important safety procedures outlined above.
FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of rubidium 82 generators to FDA’s MedWatch Adverse Event Reporting program by: