FDA Reports Excess Radiation from PET scan

The U.S. Food and Drug Administration (FDA) is now alerting healthcare professionals to stop using CardioGen-82 (manufactured by Bracco Diagnostics, Inc.) for cardiac positron emission tomography (PET) scans. The FDA reports that patients undergoing a CardioGen-82 PET scan are being exposed to excess radiation. A PET scan is a unique type of imaging test that helps doctors see how the organs are tissues inside your body are actually functioning. A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart. On July 15, 2011, the FDA alerted the pubic and the medical imaging community about the potential increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injections from CardioGen-82. At this time, the FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The FDA believes the risk of harm from this exposure is minimal, although exposure to any excessive radiation is undesirable. The current manufacturing of CardioGen-82 is under review and an investigation of the sufficiency of testing procedures at Bracco’s clinical sites is also taking place. The FDA recommends that healthcare professionals use alternatives to CardioGen-82 when planning for these types of PET scans and is asking that patients talk with their healthcare professionals for any questions or concerns. Source: http://www.fda.gov/Drugs/DrugSafety/ucm265278.htm