In mid-January, FDA updated healthcare professionals and the public regarding preliminary findings from ongoing investigations following the recall of CardioGen-82 in late July by the manufacturer, Bracco Diagnostics. The findings point to improper use of the equipment as responsible for some patients receiving excessive radiation exposure.
FDA “believes it is unlikely that this excessive exposure posed significant risks to patients, though exposure to any excessive radiation is undesirable,” according to a press release.
Bracco issued the recall after patients who received diagnostic procedures two to four months earlier set off radiation scanners at US airports (IPQ “In the News” October 31, 2011).
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 the heart.
The manufacturer 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. Preliminary data show that of 375 patients who were surveyed at 43 clinical sites, 54 patients may have received higher than normal radiation exposure. All 54 patients are from two clinical sites. Both sites “appear to have insufficient documentation of compliance with the CardioGen-82 labeling recommendations,” FDA reports.
As the use of PET therapies has become more prominent, FDA has been working through how best to regulate them. The agency held a public meeting in March, 2011 at its White Oak campus to discuss the implications of new rules on PET drug registration, listing, and inspection. Included in the discussions were the December, 2011 deadline to file new or abbreviated new drug applications (NDAs/ANDAs) for the drugs and advice on what to expect from an agency PET drug inspection (IPQ “In the News” March 27, 2011).[/membership]