2011 Nuclear Power Plant Sourcebook: Drugs for Exposure to Radioactive Iodine and Cesium - Potassium Iodide (KI) and Prussian Blue
U.S. Government, Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA), Centers for Disease Control (CDC), Agency for Toxic Substances and Disease Registry (ATSDR)
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Copyright 2011 Progressive Management
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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) * December 2001
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).
II. BACKGROUND
Under 44 CFR 351, the Federal Emergency Management Agency (FEMA) has established roles and responsibilities for Federal agencies in assisting state and local governments in their radiological emergency planning and preparedness activities. The Federal agencies, including the Department of Health and Human Services (HHS), are to carry out these roles and responsibilities as members of the Federal Radiological Preparedness Coordinating Committee (FRPCC). Under 44 CFR 351.23(f), HHS is directed to provide guidance to state and local governments on the use of radioprotective substances and the prophylactic use of drugs (e.g., KI) to reduce the radiation dose to specific organs. This guidance includes information about dosage and projected radiation exposures at which such drugs should be used.
The FDA has provided guidance previously on the use of KI as a thyroid blocking agent. In the Federal Register of December 15, 1978, FDA announced its conclusion that KI is a safe and effective means by which to block uptake of radioiodines by the thyroid gland in a radiation emergency under certain specified conditions of use. In the Federal Register of June 29, 1982, FDA announced final recommendations on the administration of KI to the general public in a radiation emergency. Those recommendations were formulated after reviewing studies relating radiation dose to thyroid disease risk that relied on estimates of external thyroid irradiation after the nuclear detonations at Hiroshima and Nagasaki and analogous studies among children who received therapeutic radiation to the head and neck. Those recommendations concluded that at a projected dose to the thyroid gland of 25 cGy or greater from ingested or inhaled radioiodines, the risks of short-term use of small quantities of KI were outweighed by the benefits of suppressing radioiodine-induced thyroid cancer. The amount of KI recommended at that time was 130 mg per day for adults and children above 1 year of age and 65 mg per day for children below 1 year of age. The guidance that follows revises our 1982 recommendations on the use of KI for thyroid cancer prophylaxis based on a comprehensive review of the data relating radioioidine exposure to thyroid cancer risk accumulated in the aftermath of the 1986 Chernobyl reactor accident.
III. DATA SOURCES
A. Reliance on Data from Chernobyl