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FDA Medwatch Alert: CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
Posted 18 Jan 2012 by Drugs.com
[UPDATED 01/12/2012] FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer. FDA continues to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites, and is working with the manufacturer to revise the CardioGen-82 labeling to better describe how to use the generator. [UPDATED 07/26/2011] FDA notified healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82. [Posted 07/15/2011] AUDIENCE: Nuclear Medicine, Radiology, Patients ISSUE: FDA notified the public and the medical imaging community about the potential for i ... Read more