Guidance on Use of Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies." This guidance updates a notice of availability entitled "Potassium Iodide as a Thyroid- Blocking Agent in a Radiation Emergency: Final Recommendations on Use" published in the Federal Register on June 29, 1982, concerning the prophylactic use of potassium iodide (KI) in the event of release of radioactive isotopes of iodine. In this guidance, FDA maintains its position that KI is a safe and effective means by which to prevent radioiodine uptake by the thyroid gland and, thus, reduce the risk of thyroid cancer in the event of a radiation emergency. The guidance recommends lower radioactive exposure thresholds for KI prophylaxis as well as lower doses of KI for neonates, infants, and children than previously recommended.