Patients Rely on Administrators to Ensure CardioGen-82 Is Used Correctly

Washington, DCFollowing the announcement that patients receiving an injection of chemicals generated by the CardioGen-82 may be at risk of receiving an increased PET radiation dose, the US Food and Drug Administration (FDA) has announced that the problem may be related to how the CardioGen-82 is administered and not due to manufacturing deficiencies. Although the FDA initially announced concern about manufacturing procedures, which prompted the CardioGen-82 recall by Bracco Diagnostics, the agency has now said the deficiencies do not appear to have caused the excess radiation in some patients.

On January 12, 2012, the FDA announced that information from investigations into the use of CardioGen-82 suggested that improper use of the CardioGen-82 at certain sites was responsible for excess exposure to radiation. Furthermore, the FDA noted that deficiencies with the manufacturing process "do not appear to have been related to the excessive radiation exposure detected in some patients." Additionally, the agency reported that of 375 patients surveyed for excess radiation, 54 had abnormal screening results and all of those 54 patients came from one of two clinical sites.

CardioGen-82 is used at medical sites to produce rubidium-82 (Rb-82), used by medical professionals to evaluate the patient's heart in a positron emission tomography (PET) scan. According to the FDA, some patients received excess radiation in the form of strontium-82 (Sr-82) and strontium-85 (Sr-85). Although the FDA says the exposure should not pose a significant risk to patients, exposure to any excess radiation is "undesireable."

Furthermore, the effects of excess levels of radiation may not be seen until years after the radiation exposure occurred, meaning patients exposed to the excess radiation could need medical monitoring for life, even if they currently show no signs of radiation toxicity.

Now that the FDA has conducted its investigation into CardioGen-82, the agency has announced that the product can return to the market, although it must carry a boxed warning about the possibility for strontium breakthrough. So far, no lawsuits have been filed against either Bracco Diagnostics or the medical centers involved in the excess radiation. It is possible that lawsuits could be filed, especially if patients are advised they will need ongoing medical monitoring or if the excess radiation appears to affect their health.