A State considering the use of potassium iodide would at least review the regulation (66 FR 5427; January 19, 2001 ), the Federal Policy on the Use of Potassium Iodide, the Food and Drug Administration (FDA) guidelines "Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies," the FEMA guidelines, and the NRC disclaimer, and would briefly deliberate the State's position on the use of potassium iodide by the general public in the unlikely event of a severe nuclear reactor .

The effectiveness of KI as a specific blocker of thyroid radioiodine uptake is well established. When administered in the recommended dose, KI is effective in reducing the risk of thyroid cancer in individuals or populations at risk for inhalation or ingestion of radioiodines. KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine.

Potassium iodide (KI) should only be taken in a radiation emergency that involves the release of radioactive iodine, such as an accident at a nuclear power plant or the explosion of a nuclear bomb. A “dirty bomb” most likely will not contain radioactive iodine. A person who is internally contaminated with radioactive iodine may experience thyroid disease later in life. The thyroid gland will absorb radioactive iodine and may develop cancer or abnormal growths later on.

Persons with known iodine sensitivity should avoid KI, as should individuals with dermatitis herpetiformis and hypocomplementemic vasculitis, extremely rare conditions associated with an increased risk of iodine hypersensitivity. Individuals with multinodular goiter, Graves' disease, and autoimmune thyroiditis should be treated with caution -- especially if dosing extends beyond a few days.

iOSAT™ Tablets are FDA approved for seven years and should be stored unopened in a dry environment at room temperature.

Many authorities on radiation exposure and thyroid cancer have made statements about the benefits of Potassium Iodide following a nuclear accident. April 3, 2003 News Release - "The American Academy of Pediatrics (AAP) recommends that households within 10 miles of a nuclear power plant keep potassium iodide (KI) on hand to protect the thyroid in the event of an accidental or intentional release of radioactive iodines ("radioiodines") into the environment.

The FDA is the Federal agency responsible for decisions about appropriate thresholds and dosages for use of potassium iodide. The FDA published their final guidelines on the use of potassium iodide and included revised dosages and intervention levels, "Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies.

There are two FDA-approved products: "Thyro-Block" (MedPointe, Inc.), approved prior to 1/1/82, and "Iosat" (Anbex, Inc.), approved 10/14/83. These products are approved for over-the-counter (OTC) use as a thyroid-blocking agent in radiation emergencies.

Since KI protects for approximately 24 hours, it should be dosed daily until the risk no longer exists. Priority with regard to evacuation and sheltering should be given to pregnant females and neonates because of the potential for KI to suppress thyroid function in the fetus and neonate. Unless other protective measures are not available, we do not recommend repeat dosing in pregnant females and neonates.

KI works best if used within 3-4 hours of exposure. Although FDA has not made specific recommendations for individual purchase or use of KI, the Nuclear Regulatory Commission has contracted to purchase KI for states with nuclear reactors and states that have population within the 10-mile emergency planning zone, e.g., Delaware or West Virginia.

Rad Block, No-Rad, LifeExtension (LEF), KI4U, NukeProtect, ProKI and KIO3 Potassium IodATE (different spelling, different drug) are not FDA Approved for radiation emergencies. The FDA has sent cease and desist letters to some of these manufacturers who recommend their product for radiation emergencies. Other products (like Rad Block) state they are manufactured in an "FDA licensed and approved over-the-counter (OTC) drug manufacturing facility".

The FDA guidance prioritizes groups based on age, which primarily determines risk for radioiodine-induced thyroid cancer. Those at highest risk are infants and children, as well as pregnant and nursing females, and the recommendation is to treat them at the lowest threshold (with respect to predicted radioactive dose to the thyroid). Anyone over age 18 and up to age 40 should be treated at a slightly higher threshold.