-Caveat Lector- >From http://thyroid.about.com/library/news/blfdapotassiumiodide.htm
>>>Note that I have only provided the Intro; all the title bullets are hot linques to areas further on down the page. Go to the site for the complete report. A<>E<>R<<< }}}>Begin FDA Guidance: Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies December, 2001 SOURCE: FDA Center for Drug Evaluation and Research Guidance Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) November 2001 Procedural Additional copies are available from: Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 (Internet) http://www.fda.gov/cder/guidance/ index.htm TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND III. DATA SOURCES A. Reliance on Data from Chernobyl B. Thyroid Cancers in the Aftermath of Chernobyl IV. CONCLUSIONS AND RECOMMENDATIONS A. Use of KI in Radiation Emergencies: Rationale, Effectiveness, Safety B. KI Use in Radiation Emergencies: Treatment Recommendations V. ADDITIONAL CONSIDERATIONS IN PROPHYLAXIS AGAINST THYROID RADIOIODINE EXPOSURE VI. SUMMARY ACKNOWLEDGEMENTS BIBLIOGRAPHY Guidance Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. I. INTRODUCTION The objective of this document is to provide guidance to other Federal agencies, including the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC), and to state and local governments regarding the safe and effective use of potassium iodide (KI) as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment. The adoption and implementation of these recommendations are at the discretion of the state and local governments responsible for developing regional emergency-response plans related to radiation emergencies. This guidance updates the Food and Drug Administration (FDA) 1982 recommendations for the use of KI to reduce the risk of thyroid cancer in radiation emergencies involving the release of radioactive iodine. The recommendations in this guidance address KI dosage and the projected radiation exposure at which the drug should be used. These recommendations were prepared by the Potassium Iodide Working Group, comprising scientists from the FDA's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) in collaboration with experts in the field from the National Institutes of Health (NIH). Although they differ in two respects (as discussed in Section IV.B), these revised recommendations are in general accordance with those of the World Health Organization (WHO), as expressed in its Guidelines for Iodine Prophylaxis Following Nuclear Accidents: Update 1999 (WHO 1999). 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