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Executive Summary

CONTRAST AGENT SUBARACHNOID HEMORRHAGE WARNING STATEMENT should be added to product labeling, FDA's Radiophar-maceutical Drugs Advisory Cmte. recommended at its May 18 meeting. The cmte. suggested that labeling include the statement: "In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and deaths, has been reported. Therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution." Although the cmte. agreed the labeling should warn of the potential hazard of contrast administration in patients with subarachnoid hemorrage, the cmte. did not believe subarachnoid hemorrhage should be a contraindication. In response to a question from FDA, the cmte. agreed contrast agents should not be proscribed "if subarachnoid hemorrhage is suspected or known to be present from clinical or unenhanced CT data." Anne Osborn, MD, University of Utah Medical School, told the cmte. that "actual extravasation of contrast during subarachnoid hemorrhage is so rare that is is virtually reportable in the literature." She estimated a prevalence of "one in 5,000 or 6,000 cases." FDA also asked the cmte. if it would recommend delivery of the contrast agent by infusion rather than bolus injection in this clinical situation and the cmte. responded that there was "not a shred of evidence" to support such a suggestion. Commenting on radiopharmaceutical package inserts, FDA Office of Drug Research & Review Director Robert Temple, MD, questioned the absence of label instructions on how to use the product and how to interpret test results. He suggested it would be "worth providing some information on how to interpret" a radiopharmaceutical test and "how to even convert whatever you're measuring into a blood flow measurement." Cmte. chairman Barry Siegel, MD, Washington University School of Medicine, said a reference in the label to point the physician in the right direction would be more effective than including detailed information since "the labeling cannot be a nuclear medicine textbook" related to a particular drug.

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