In an October 17 letter to its customers, contrast agent developer Bracco Diagnostics said that it may be able to resume production of its CardioGen-82 (rubidium-82 chloride injection) PET tracer in the first or second quarter of 2012.
In July, the U.S. Food and Drug Administration (FDA) notified healthcare professionals not to use CardioGen-82 after two reports that patients injected with the agent had received increased radiation exposure during the PET scans. The incidents were due to strontium isotopes that may have been inadvertently injected into patients because of a "strontium breakthrough" problem with CardioGen-82, according to the agency.
The FDA announcement prompted Bracco to voluntarily recall the cardiac PET imaging agent.
Since then, Bracco has contacted customer sites that administered CardioGen-82 to patients from January 2011 through July 2011 to garner additional information about incidence of unexpected exposure.
Bracco's communiqué to customers also stated that the company is revalidating its manufacturing process, in addition to reviewing labeling and user training to ensure proper generator use. Bracco has also been in contact with the FDA to investigate the root cause of the unexpected radiation and to address the FDA's concerns.
"Our investigation findings, to date, continue to support that the unexpected radiation levels may have been due to user error or strontium breakthrough higher than what is expected with normal generator use or a combination of both," the letter stated. "Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end."
Bracco has proposed a phased reintroduction of CardioGen-82 generators to customer facilities, with data collection and evaluation of the actual field use of each generator.
Based on the outcome of its reintroduction discussions with the FDA, Bracco anticipates a limited and progressive reintroduction of the product to commence in the first or second quarter of 2012.
