What is IOSAT™ Potassium Iodide? (chemical abbreviation is KI)
IOSAT™ KI is the only FDA-approved blister-packaged thyroid blocking product available to the public. Potassium Iodide is used by governments worldwide to prevent thyroid cancer in people who are exposed to radiation iodines caused by nuclear reactor accidents and nuclear bombs. IOSAT™ KI protects against radioactive iodine by preventing its absorption by the thyroid gland located in the neck. Thyroid cells are unique among all cells of the human body as they are the only cells which have the ability to absorb Iodine. The thyroid gland absorbs it from the bloodstream and concentrates it inside the cell to produce hormones. For radiation that is not immediately lethal, the thyroid is your body's most sensitive organ to the effects of radiation. The Radioactive Iodine is absorbed by the thyroid and can cause thyroid disease and cancer later on. Sometimes it only takes a short time if the victim is a child because a child’s thyroid is very active in helping the child to grow. FDA Approved IOSAT™ KI saturates the thyroid with stable iodine, shutting off its absorption mechanism, and it will remain off long enough for the radioactive iodine that you inhaled or ingested to to be safely dispursed through the kidneys.
How much should I buy?
We recommended one pack per person for storing at home. Each pack has 14 130mg tablets. However, you should consider stocking IOSAT outside the home as well. You wouldn't want to get caught without Potassium Iodide if something should happen.
Can I give it to my child easily?
A whole pill is the size of a baby aspirin and is scored for easy and exact separation for half dosages if desired. For children who won't swallow pills, crush it up and administer it with applesauce, yogurt, formula, juice, etc.
What is the dosage?
On December 10, 2001 the FDA released a guidance on potassium iodide. The guidance issued is not just for the 10-mile Emergency Planning Zone, but for any and all areas potentially affected. Close in, there may not be time to deal with fractional dosage of Potassium Iodide (see below). The guidance acknowledges that strict adherence to the age-related dosing guidelines may be difficult to achieve and, therefore, emphasizes that across populations at risk for radioiodine exposure, the overall benefits of potassium iodide far exceed the risks of overdosing, especially in children, though particular attention should be paid to dose and duration of treatment in infants and in pregnant women.
You can follow these FDA links to read what they say about administering even a whole pill to a child.
Below are the Daily Dosages (one dose every 24 hours - the pills are scored for easy separation for child dosages if desired) Following either dosage guideline will be both safe and effective.
Maximum Effective Dose - (The most you can safely administer if you don't have time to deal with fractional dosing)
Birth to 1 year 65mg daily (1/2 IOSAT tablet)
Age 1 to Adult 130mg daily (One IOSAT tablet)
Minimum Effective Dose - (The least you can administer and still be protected from radioactive iodine)
Age 18+* 130mg daily (One IOSAT tablet)
Age 3 - 18** 65mg daily (1/2 IOSAT tablet)
1 month - 3 yrs. 32mg daily (1/4 IOSAT tablet)
Birth - 1 month 16mg daily (1/8 IOSAT tablet)
*Note that adults over 40 need take IOSAT™ KI only in the case of a projected large internal radiation dose to the thyroid (>500 cGy) to prevent hypothyroidism. However, adults over 40 should still stock Potassium Iodide as the amount of released radiation cannot be predicted and short-term administration of KI (Potassium Iodide) at thyroid blocking doses is safe, even if not needed.
**Adolescents approaching adult size (approx.100+ lbs.) should receive the full adult dose (130 mg).
Repeat dosing of IOSAT™ KI should be avoided in the neonate to minimize the risk of hypothyroidism during that critical phase of brain development. KI may be crushed and diluted in milk, formula, water, juice, applesauce, etc. and the appropriate volume administered to babies or small children. As stated above, we recommend that neonates (within the first month of life) treated with IOSAT™ KI be monitored for the potential development of hypothyroidism and that thyroid hormone therapy be instituted in cases in which hypothyroidism develops. Pregnant women should be given IOSAT™ KI for their own protection and for that of the fetus, as iodine (whether stable or radioactive) readily crosses the placenta. However, because of the risk of blocking fetal thyroid function with excess stable iodine, repeat dosing with IOSAT™ KI of pregnant women should be avoided. Lactating females should be administered IOSAT™ KI for their own protection, as for other young adults, and potentially to reduce the radioiodine content of the breast milk, but not as a means to deliver IOSAT™ KI to infants, who should get their IOSAT™ KI directly. As for direct administration of IOSAT™ KI, stable iodine as a component of breast milk may also pose a risk of hypothyroidism in nursing neonates. Therefore, repeat dosing with IOSAT™ KI should be avoided in the lactating mother, except during continuing severe contamination. If repeat dosing of the mother is necessary, the nursing neonate should be monitored as recommended above.
When should I take it? When should I stop?
For optimal protection against inhaled radioiodines, IOSAT™ KI should be administered before the passage of the radioactive iodine plume, though IOSAT™ KI may still have a substantial protective effect even if taken 3 or 4 hours after exposure. Take one dose as soon as possible and then every 24 hours at the same time each day. Take the pill only when exposed to radioactive iodine (and as notified by health officials). Furthermore, if the release of radioiodines into the atmosphere is protracted, then, of course, even delayed administration may reap benefits by reducing, if incompletely, the total radiation dose to the thyroid. As time is of the essence in optimal prophylaxis with IOSAT™ KI, timely administration to the public is a critical consideration in planning the emergency response to a radiation accident and requires a ready supply of IOSAT™ KI. Potassium Iodide 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 IOSAT™ KI should be as an adjunct to evacuation (itself not always feasible), sheltering, and control of food stuffs.
Do I need a prescription? What about FDA Approval?
Because of the inherent safety of IOSAT™ KI, the FDA allows IOSAT™ KI to be sold without a prescription for radiation protection. Its use, however, should be limited to radiation emergencies, and only when recommended by emergency response authorities. Concerning FDA Approval, IOSAT Potassium Iodide is the only FDA Approved Potassium Iodide readily available to the public, having individually foil-sealed pills (ensures product integrity). Ask yourself - If you had cancer and could take a pill that would cure it, would you take an FDA regulated and approved pill, or a non-approved pill? Then ask - If you could take a pill to possibly prevent cancer would you take an FDA Approved pill or a non-approved pill? Rad Block™ and Potassium IodATE (different spelling, different drug) are not FDA Approved.
Is it safe? Who should and shouldn't take it?
Potassium iodide is extremely safe in the dosage provided by IOSAT™ KI. Because it is widely used in other treatments, its effects are well known. Calculations by the National Council on Radiation Protection suggest that the incidence of adverse reactions to the Potassium Iodide (KI) in IOSAT™ KI can be as low as 1 in 10 million, and often no more than a mild skin rash. In the 1930s the government required salt manufacturers to add Potassium Iodide to its table salt (like Morton salt) because people in the great lakes region had iodine-deficient diets and had a high rate of goiters and other thyroid problems. Potassium Iodide is also added to children's Flinstone vitamins because it is an essential mineral. It has also been used as a children's expectorant for years.
From the FDA - "Short-term administration of KI (Potassium Iodide) at thyroid blocking doses is safe and, in general, more so in children than adults. The risks of stable iodine administration include sialadenitis (an inflammation of the salivary gland, of which no cases were reported in Poland among users after the Chernobyl accident), gastrointestinal disturbances, allergic reactions and minor rashes. In addition, 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. Thyroidal side effects of stable iodine include iodine-induced thyrotoxicosis, which is more common in older people and in iodine deficient areas but usually requires repeated doses of stable iodine. In addition, iodide goiter and hypothyroidism are potential side effects more common in iodine sufficient areas, but they require chronic high doses of stable iodine. In light of the preceding, individuals with multinodular goiter, Graves' disease, and autoimmune thyroiditis should be treated with caution, especially if dosing extends beyond a few days. The vast majority of such individuals will be adults. The transient hypothyroidism observed in 0.37 percent (12 of 3214) of neonates treated with KI in Poland after Chernobyl has been without reported sequelae to date. There is no question that the benefits of KI treatment to reduce the risk of thyroid cancer outweigh the risks of such treatment in neonates. Nevertheless, in light of the potential consequences of even transient hypothyroidism for intellectual development, we recommend that neonates (within the first month of life) treated with KI be monitored for this effect by measurement of TSH (and FT4, if indicated) and that thyroid hormone therapy be instituted in cases in which hypothyroidism develops".
Pregnant women should take it for their own protection and for that of the fetus, as iodine (whether stable or radioactive) readily crosses the placenta. However, because of the risk of blocking fetal thyroid function with excess stable iodine, repeat dosing with IOSAT™ KI of pregnant women should be avoided. Lactating females should be take it for their own protection to reduce the radioiodine content of the breast milk, but not as a means to deliver IOSAT™ KI to infants, who should get their IOSAT™ KI directly.
Can I give it to my pets?
There have been no studies concerning animals and the administration of Potassium Iodide for radiation emergencies. Like humans, animals do not normally have any allergic reaction to limited doses of Potassium Iodide. For animals with no known iodine allergies (ask your vet) it is a relatively safe drug. If you wish to administer it to your pet, follow the human dosage amounts listed below in the "What is the dosage?" info and give the appropiate dosage based upon weight. For instance, the dosage for a 2-year-old child would be 32mg (1/4 tablet). If an average 2-year-old weighs 25 -30 lbs., a dog weighing the same would take the same dosage, 32mg (1/4 tablet). If a 2-week-old infant weighs on average 9 pds., then you would give a 9 pound cat/dog 16mg (1/8 tablet). Crush it up and put it in their food. Please consult with a vet in advance to make sure your pet can safely take Potassium Iodide (found in table salt, fish oil, kelp, daily vitamins, etc.)
What about other Potassium Iodide (KI) products? Or Potassium IodATE? Are they FDA approved?
There are only two brands of drugs that are FDA approved for radiation protection. And IOSAT™ is the only one foil-sealed and available to the public. Rad Block™ and Potassium IodATE (different spelling, different drug) are not FDA Approved 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". Well, the facility might be FDA licensed but their Potassium Iodide is not mandated under strict FDA “GMP guidelines,” nor do they hold an approved “New Drug Application” (NDA) for KI. The incoming raw materials and outgoing Potassium Iodide pills are not approved by the FDA. (During a nuclear emergency would you want to give your family a non-FDA-approved drug that cost more?)
But they say they were registered with the FDA and have a National Drug Code (NDC) number to prove it! The NDC serves as a universal product identifier for human drugs. An NDC number does not indicate that a drug is FDA approved. FDA’s regulation at 21 C.F.R.207.39 specifically proves that: registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC number does not in any way denote approval of the firm or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and constitutes misbranding. Instead, drug approval involves a completely different process, which includes the submission by a manufacturer of a new drug application (NDA) or an abbreviated new drug application (ANDA), which FDA then may approve - International Academy of Compounding Pharmacists.
What is the shelf life?
Though the FDA currently requires us to state an actual expiration date (5 years from date of manufacture), if kept dry in its packaging, it can last for years. No IOSAT™ KI has ever failed to meet all specifications by the FDA. In a recent test, IOSAT™ KI produced 16 years ago were assayed and found to be as effective as the day they were manufactured.