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Cardiology: FDA Warns Healthcare Professionals to Avoid PET Scan Agent

by Robert Fay

The U.S. Food and Drug Administration (FDA) has warned healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. CardioGen-82 is a radionuclide generator that produces rubidium (Rb)-82 chloride injection. Rb-82, which is derived from strontium-82, is collected from the generator column by injecting a solution of normal saline through the column. Normally, only the Rb-82 is released into the solution, and strontium remains attached to the column.

In a July 15, 2011 drug safety communication, the FDA warned of potential increased radiation exposure to patients who underwent or who would undergo cardiac PET scans with Rb-82 from CardioGen-82 after the agency received reports of two people who received more radiation than expected. The excess radiation came from strontium isotopes, which the FDA believes was the result of a “strontium breakthrough” problem with CardioGen-82. After investigating further, the FDA concluded that the manufacturing procedures were insufficient to prevent additional strontium breakthroughs. The FDA recommended that healthcare professionals use alternatives to CardioGen-82 generator. Bracco Diagnostics, Inc., the agent's manufacturer, has voluntarily recalled CardioGen-82.

Sources: U.S. Food and Drug Administration. 2011. FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients. Published on July 26, 2011 on the FDA website.

U.S. Food and Drug Administration. 2011. FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans. Published on July 15, 2011 on the FDA website.