Potassium Iodide (FDA Summary Report follows)
VI. SUMMARY <http://www.fda.gov/cder/guidance/4825fnl.htm#SUMMARY>
FDA maintains that KI is a safe and effective means by which to prevent radioiodine uptake by the thyroid gland, under certain specified conditions of use, and thereby obviate the risk of thyroid cancer in the event of a radiation emergency. Based upon review of the literature, we have proposed lower radioactive exposure thresholds for KI prophylaxis as well as lower doses of KI for neonates, infants, and children than we recommended in 1982. As in our 1982 notice in the Federal Register, FDA continues to recommend that radiation emergency response plans include provisions, in the event of a radiation emergency, for informing the public about the magnitude of the radiation hazard, about the manner of use of KI and its potential benefits and risks, and for medical contact, reporting, and assistance systems. FDA also emphasizes that emergency response plans and any systems for ensuring availability of KI to the public should recognize the critical importance of KI administration in advance of exposure to radioiodine. As in the past, FDA continues to work in an ongoing fashion with manufacturers of KI to ensure that high-quality, safe, and effective KI products are available for purchase by consumers as well as by state and local governments wishing to establish stores for emergency distribution.
KI provides protection only for the thyroid from radioiodine. It has no impact on the uptake by the body of other radioactive materials and provides no protection against external irradiation of any kind. FDA emphasizes that the use of KI should be as an adjunct to evacuation (itself not always feasible), sheltering, and control of foodstuffs.
NRC Potassium Iodide Article
The Consideration of Potassium Iodide in Emergency Planning
The Nuclear Regulatory Commission has revised a section of its emergency preparedness regulations. The revised rule requires that States* with a population within the 10-mile emergency planning zone of commercial nuclear power plants consider including potassium iodide as a protective measure for the general public to supplement sheltering and evacuation in the unlikely event of a severe nuclear power plant accident.
Along with this rule change, the NRC is providing funding for a supply of potassium iodide for a State that chooses to incorporate potassium iodide for the general public into their emergency plans. After funding the initial supply of potassium iodide, the Commission may consider extending this program to fund replenishment supplies, but has made no committments in this regard.
Potassium iodide is a salt, similar to table salt. Its chemical symbol is KI. It is routinely added to table salt to make it "iodized." Potassium iodide, if taken within the appropriate time and at the appropriate dosage, blocks the thyroid gland's uptake of radioactive iodine and thus reduces the risk of thyroid cancers and other diseases that might otherwise be caused by thyroid uptake of radioactive iodine that could be dispersed in a severe reactor accident.
The NRC and the Federal Emergency Management Agency (FEMA) are the two Federal agencies responsible for evaluating emergency preparedness at and around nuclear power plants. The NRC is responsible for assessing the adequacy of onsite emergency plans developed by the utility, while FEMA is responsible for assessing the adequacy of offsite emergency planning. The NRC relies on FEMAs findings in determining that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency.
The Food and Drug Administration (FDA) is the definitive medical authority in the United States on the use of potassium iodide.
FAQ Potassium Iodide
What is KI80?
KI80 is a substance called potassium iodide. It is non-toxic and safe for human consumption. (It is the same ingredient found in table salt.)
How does potassium iodide
Potassium iodide acts as a thyroid-blocking agent. When potassium iodide is administrated at the proper time, it is absorbed in the thyroid gland, filling up the gland, which prevents radioactive iodines from entering.
Is potassium iodide safe?
In 1978 the FDA stated the potassium iodide was found safe and effective in the event of a radiological emergency.
Do you need a prescription
No. Potassium iodide has been approved by FDA as an over the counter medication.
Source: (1) Click Here: "Federal Drug Administration Guidance - Potassium Iodide Guidance" (2)Click Here: NRC: Federal Register Notice January 16, 2001
Who cannot take KI80?
Individuals who are allergic to iodine should not take KI80. Persons with a history of thyroid disease should not take KI80. In addition, persons with dermatitis herpetiformis and hypocomplementemic vasculitis should also avoid taking KI80. As with all medication, individuals should check with their physicians first, especially if they are already on medications or their general health is questionable.
Source: Click Here: "Federal Drug Administration Guidance - Potassium Iodide Guidance"
Can pregnant women take KI80?
Pregnant women should be given KI80 for their own protection and for that of the fetus. However, because of the risk of blocking fetal thyroid function with excess stable iodine, repeat dosing with KI80 of pregnant women should be avoided.
Why should I take KI80?
Taking KI80 in the event of a radioactive emergency will help protect your thyroid glands against harmful contaminated air. Thyroid cancer is one of the main causes of death after radiation exposure. Potassium iodide has been proven to prevent cancer in the thyroid glands.
Can children take KI80?
Yes. Children are more susceptible to thyroid cancer than adults; however, potassium iodide is more effective in children than adults. (NRC)
When should KI80 be taken?
KI80 should only be taken when in the event of a radiation emergency and only when public health officials, (such as state or local authorities), advice you to do so. The sooner KI80 is administrated, the more protection you have from radioactive iodine.
How long should I take potassium iodide?
You should take potassium iodide as long as health officials recommend, usually only a few days.
Are there any side
Possible side effects include, a skin rash, swelling of the salivary gland, gastrointestinal upset, or an allergic reaction. Although few people have serious symptoms to potassium iodide, if this should happen, stop taking KI80 and call your physician.
How often should KI be given?
One dose per day. Potassium iodide last 24 hours in your system. Taking more than recommended will not benefit more.
If I take KI80 will it
totally protect me?
Understanding KI80 is crucial. It is not a miracle drug and does not replace the need to evacuation and seek shelter. However, when evacuation and shelter are not feasible, KI80 is protective measure only for the thyroid glands
Potassium Iodide <http://www.ki4u.com/>
"They suggest that the risk of thyroid cancer is inversely related to age, and that, especially in young children, it may accrue at very low levels of radioiodine exposure." and also that "...adults over 40 need take KI only in the case of a projected large internal radiation dose to the thyroid (>500 cGy) to prevent hypothyroidism."
Dosing chart from the recently
updated 1999 World Health Organization:
WHO - Guidelines for Iodine Prophylaxis following Nuclear Accidents
|Age Group||Mass of iodine
|Mass of KI
|Mass of KIO3
100 mg tablet
|Adults and adolescents
(over 12 years)
(1 month to 3 years)
(birth to 1 month)
To help make sense of any possible dosing confusion and radiation level thresholds, it should be remembered first that you should not commence dosing until so directed by a doctor or public health officials. Also, the biggest difference in dosage and ages, between the two recommendations, is that WHO suggests an adult dose (130mg KI) for everyone over 12 where the FDA suggests an adult dose for everyone over 18, unless the adolescent weighs 70kg (154 lbs) or more. And, again, the primary reason for this divergence from the WHO recommendations is that, according to the FDA: For the sake of logistical simplicity in the dispensing and administration of KI to children, FDA recommends a 65-mg dose as standard for all school-age children while allowing for the adult dose (130 mg, 2 X 65 mg tablets) in adolescents approaching adult size.
At the WHO dosages recommended above, an adverse reaction rate of less than 1 in 10 million children and less than 1 in 1 million adults is expected. However, Potassium Iodide should not be used by people allergic to iodine. According to the WHO, contraindications for use of potassium iodide are: (1) past or present thyroid disease (e.g., active hyperthyroidism), (2) known iodine hypersensitivity, (3) dermatitis herpetiformis, and (4) hypocomplementaemic vasculitis.
You should also check with your doctor before taking this medication if you have myotonia or hyperkalemia congenita or tuberculosis or kidney disease. See http://www.mayoclinic.com/ for more information.
Pregnant women should consult a physician prior to continuing dosages for more than two days. According to the WHO, "No negative consequences are to be expected after one or two doses of stable iodine. However, especially in areas with dietary iodine deficiency, prolonged dosage could lead to maternal and/ or fetal thyroid blockage, with possible consequences for fetal development. ... Pregnant women with active hyperthyroidism must not take stable iodine because of the risk of fetal thyroid blockage."
The WHO also states, and the FDA concurs, "Side effects in other parts of the body, such as gastrointestinal effects or hypersensitivity reactions, may occur but are generally mild and can be considered of minor importance."
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