FDG F 18 injection for both the oncology and myocardial hibernation indications, FDA considered the approximately two decades of clinical use of the drug and the conclusions the agency reached in approving NDA 20-306 for this drug. The currently labeled intravenous doses of FDG F 18 injection for epilepsy are 5 to 10 millicuries (mCi) in adults and 2.6 mCi in pediatrics. No significant adverse reactions have been reported for FDG F 18 injection. In addition, FDA found no reports of adverse reactions in the published literature on the effectiveness of FDG F 18 injection or in a recent article by Silberstein and others (1996) reporting the results of a 5-year prospective study on drugs used in nuclear medicine,at 18 collaborating institutions. The literature and FDA's finding on the safety of FDG F 18 injection in NDA 20-306 indicate that for an intravenous dose of 10 mCi of the drug, the critical target organ (the bladder) absorbs only 6.29 rems based on a fixed bladder content over a 3-hour period. For higher doses, the level and extent of radiation absorbed by the bladder walls can be manipulated with hydration and shorter voiding intervals to decrease radiation exposure. On the basis of this information, a 10-mCi dose of FDG F 18 injection appears to pose a relatively low risk to adult patients.
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