Issue Date: December 11, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies

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 emergencyresponse 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.

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