Positron Corporation : CardioGen-82 Recall Officially Ends
02/06/2012 | 10:42am
February 3, 2012 - Bracco Diagnostics' recall of
its CardioGen-82 cardiac PET radiopharmaceutical is
officially over.
In a podcast on February 1, the U.S. Food and Drug
Administration (FDA) confirmed that improper use of
CardioGen-82 at two clinical sites caused three patients to
be exposed to more radiation than typically associated with a
CardioGen-82 scan.
Lesley Navin, a consumer safety officer in the
FDA's Division of Drug Information, said the increased
radiation exposure was due to administration of CardioGen-82
generator eluates that contained excess concentrations of
strontium-82 (Sr-82) and strontium-85 (Sr-85), a phenomenon
known as "strontium breakthrough."
The FDA believes it is "unlikely that this
excessive exposure posed significant risks to patients,
though exposure to any excessive radiation is
undesirable," she added.
In July 2011, the FDA began investigating whether
Bracco's manufacturing procedures for CardioGen-82 may
have caused the incidents. However, the agency concluded this
week that the company was not to blame for the excess
radiation.
"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," Navin said. "None of the
tested generators showed signs of breakthrough."
For several months now, Bracco has been in contact with
its customers across the U.S. to assess the extent to which
patients may have been exposed to excessive radiation.
According to the FDA, 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 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,"
Navin added.
The FDA is also working with Bracco to enhance the
labeling for CardioGen-82 to better describe how to use the
generator and to implement a plan for returning CardioGen-82
to the market.
