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No. R - 2 0 5 FOR IMMEDIATE RELEASE q55 Contact: Gail Bradshaw (Monday, May 1 4 , 1973) AEC HALTS USE OF R4DIOPHARVACEUTICAL I X LUNG SCANS The Atomic Energy Commission has ordered its licensees to stop using for lung scans a technetium 99m labelled iron compound made from a kit manufactured by Diagnostic Isotopes, Inc. The AEC action was taken after a report that three patients died .at Georgetown University Hospital, Washington, D.C., within 30 minutes of injection of the compound, although the report indicated the three were ill at the time, and the role, if any, of the drug is not clear. The radioactive technetium in the drug is not implicated in t h e deaths since the amount is small and technetium has been used safely ind effectively with other chemical compounds for years in diagnosing millions of patients. Clinical tests with the radiopharmaceutical had been approved by the AEC at only three hospitals in the nation. Other hospitals having broad AEC licenses had been conducting similar tests following approval by their individual investigational drug review committees. Physicians and hospitals using radiopharmaceuticals in this country must have a license from the Atomic Energy C o m - rissicn or one of the states Khich have assumed that portion of the AEC ' s regulatory responsibilities. At the same time licensees were ordered to stop using this radiopharmaceutical, AEC licensing officials advised state governments of the situation. The AEC learned of the deaths through an announcement from the Society of Nuclear Medicine listing papers to be presented at its June 1973 meeting. One of the papers listed was titled "Fatal Reactions Following 99m Technetium Ferrous Hydroxide Lung Scans." Two of the four authors of the paper were contacted by AEC officials to obtain details.
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The drug had been administered to 1 7 7 patients over a seven-month period at Georgetown University Hospital which has a broad AEC license. The three deaths occurred within 30 minutes o f administration under circumstances which implicate the drug compound. Though all three who died were quite ill at the time and the exact role played by the drug, if any, is not clear, AEC Regulatory officials felt the implications were sufficient to halt temporarily its further use on humans. A full study will be conducted. Stopping the use of this particular radiopharmaceutical kit will not deny the benefits of lung scans to patients who need them. There are readily available alternatives that are considered t o be safe, including other compounds using