Positron emission tomography (PET) scan drug CardioGen-82 may cause increased radiation exposure, the Food and Drug Administration announced Tuesday, and the agency is warning doctors to stop using the drug.
The drug, manufactured by Italian company Bracco Diagnostics Inc., is used in positron emission tomography scans to diagnose heart disease. On July 15 the FDA found that two patients who had undergone these scans months earlier had detectable levels of radiation.
The active ingredient in CardioGen-82 is rubidium, which is generated by strontium isotopes that may have been inadvertently injected into patients after a "strontium breakthrough" problem. Though the root cause is unclear, the agency has determined that the manufacturing procedures "are not sufficient to ensure reliable performance" of the drug.
The FDA told Dow Jones Newswires that the radiation levels seen in the two patients is similar to cumulative radiation levels from other heart scans. CardioGen-82 has been used for positron emission tomography scans since 1989. Bracco is voluntary recalling the product and working with officials to investigate.
