|Iosat Potassium Iodide Tablets FAQ
1. What is radioactive iodine?
- Answer: One of the most feared consequences of a nuclear reactor accident or nuclear bomb is the release of a radioactive iodine plume into the environment. Radioactive Iodine (I-131) is a by-product of nuclear fission which occurs only within a nuclear reactor or during detonation of a nuclear bomb. What makes radioactive iodine so dangerous is that the body cannot distinguish it from ordinary iodine. As a result, if swallowed (in contaminated food or water), or inhaled (it can remain in the atmosphere for days), it will be absorbed into the thyroid gland (only the thyroid absorbs iodine) and may lead to thyroid cancer, especially in children. The value of Potassium Iodide (KI) tablets were demonstrated following the Chernobyl nuclear accident, where authorities began mass distribution of Potassium Iodide just hours after the explosion. In the years following the accident in areas where people received the drug, the incidence of thyroid cancer has not increased. But where Potassium Iodide was not distributed, previously rare forms of juvenile thyroid cancer have begun appearing at epidemic rates, with over 11,000 known cases. This number continues to rise and is not expected to peak until 2010.
2. What is Potassium Iodide? (chemical abbreviation is KI)
- Answer: Potassium Iodide (KI) is used by health officials worldwide to prevent thyroid cancer in people who are exposed to radioactive iodides caused by nuclear reactor accidents and nuclear bombs. It 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 and ThyroShield 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 disbursed through the kidneys. IOSAT KI is the only FDA-approved full strength thyroid blocking tablet available to the public.
3. Will potassium iodide radiation tablets protect me against a "dirty bomb"?
- Answer: A "dirty bomb" is a conventional explosive, such as dynamite, salted with radioactive waste that scatters when the bomb goes off. The bomb can kill or injure through the initial blast of the conventional explosive and possibly through the dispersal of the radioactive materials-- hence the term "dirty." Such bombs could be small devices or as big as a truck bomb. There are four categories of radioactive waste ranging from very low-level waste that can be safely disposed of with ordinary refuse, to high-level waste such as spent nuclear fuel. Substantial amounts of radioactive waste are generated through civilian and military applications of radionuclides in medical facilities, food irradiation plants, chemical and manufacturing plants, etc. Some types of radioactive waste would be easier to obtain than others in order to make a "dirty bomb". Radiation detectors are needed to alert officials of their presence.
4. How do I know if there is radiation in my area?
- Answer: By using a radiation detector, emergency officials, such as FEMA, can monitor the environment for detectable levels of radiation. One would hope that they are in your area with their equipment as quick as possible and that they report this information to the public immediately. Of course, they cannot follow you and your family around with their detectors and tell you if you specifically have retreated to a safe environment away from the radiation.
5. Do I need a prescription?
- Answer: Because of the inherent safety of Potassium Iodide that is FDA Approved, it is available without a prescription for radiation protection. Its use, however, should be limited to radiation emergencies and only when recommended by emergency response authorities.
6. What about FDA Approval?
- Answer: IOSAT Potassium Iodide is the only full strength brand tested and approved by the FDA for radiation emergencies.
7. How much should I buy?
- Answer: We recommended one Iosat pack per person for storing at home. Each Iosat pack has 14 130mg tablets. A two week supply for an adult and a 28+ day supply for a child. However, you should consider stocking Potassium Iodide outside the home as well. You wouldn't want to get caught without Potassium Iodide if something should happen. Can you imagine the traffic jam as everyone leaves town at the same time?
8. Can I give it to my child easily?
- Answer: A whole Iosat pill is the size of a baby aspirin and is scored for easy and exact separation for half and quarter dosages if desired.
9. What is the dosage?
- Answer: 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.
10. When should I take it? When should I stop?
- Answer: For optimal protection against inhaled radioiodines, Potassium Iodide should be administered before the passage of the radioactive iodine plume, though Potassium Iodide 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 potassium iodide only when exposed to radioactive iodine as notified by state or local public 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 Potassium Iodide, timely administration to the public is a critical consideration in planning the emergency response to a radiation accident and requires a ready supply of Potassium Iodide. 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 Potassium Iodide should be as an adjunct to evacuation (itself not always feasible), sheltering, and control of food stuffs.
11. Is it safe? Who should and shouldn't take it?
- Answer: Potassium iodide is extremely safe in the dosage provided by IOSAT and ThyroShield. 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 Potassium Iodide 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 Flintstone vitamins because it is an essential mineral. It has also been used as a children's expectorant for years.
Repeat dosing of Potassium Iodide should be avoided in the neonate to minimize the risk of hypothyroidism during that critical phase of brain development. As stated above, we recommend that neonates (within the first month of life) treated with Potassium Iodide 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 Potassium Iodide 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 Potassium Iodide of pregnant women should be avoided. Lactating females should be administered Potassium Iodide 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 Potassium Iodide to infants, who should get their Potassium Iodide directly. As for direct administration of Potassium Iodide, stable iodine as a component of breast milk may also pose a risk of hypothyroidism in nursing neonates. Therefore, repeat dosing with Potassium Iodide 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.
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 Potassium Iodide 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 Potassium Iodide to infants, who should get their Potassium Iodide directly.
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".
12. Can I give it to my pets?
- Answer: 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 potassium iodide to your pet, follow the Iosat dosing chart amounts listed above in the "What is the dosage?" info and give the appropriate 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 pounds, 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.
Note: Iodine is found in table salt, fish oil, kelp, daily vitamins, etc.)
13. What is the shelf life?
- Answer: 7 year shelf-life from date of manufacture for IOSAT
14. What do the experts say about potassium iodide?
- Answer: Many authorities on radiation exposure and thyroid cancer have made statements about the benefits of Potassium Iodide following a nuclear accident.
American Academy of Pediatrics
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. Schools and child care facilities within the same radius also should have immediate access to KI. It may be prudent to consider stockpiling KI within a larger radius because of more distant windborne fallout".
Dept of Homeland Security - Ready.gov
"Consider keeping potassium iodide in your emergency kit, learn what the appropriate doses are for each of your family members".
FEMA - Nuclear Power Plant Preparedness Document
"The thyroid gland is vulnerable to the uptake of radioactive iodine. If a radiological release occurs at a nuclear power plant, States may decide to provide the public with a stable iodine, potassium iodide, which saturates the thyroid and protects it from the uptake of radioactive iodine. Such a protective action is at the option of State, and in some cases, local government".
In December 2001, the Food and Drug Administration released their final guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies. Quote - "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". FDA December 2001
World Health Organization
In 1999 the World Health Organization (WHO) updated their Guidelines for Iodine Prophylaxis Following Nuclear Accidents. Quote - "Stable iodine administered before, or promptly after, intake of radioactive iodine can block or reduce the accumulation of radioactive iodine in the thyroid. Intake of radioactive iodine by inhalation begins when the radioactive cloud arrives at a location and continues during the passage of the cloud. Action to implement stable iodine prophylaxis, and thereby reduce the dose to the thyroid, will be required promptly". WHO 1999
Nuclear Regulatory Commission (NRC)
"The Nuclear Regulatory Commission (NRC) is amending its emergency planning regulations governing the domestic licensing of production and utilization facilities. The final rule requires that consideration be given to including potassium iodide (KI) as a protective measure for the general public that would supplement sheltering and evacuation. KI would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant". - NRC January 2001
Remarks on the need for potassium iodide made by Commission Chairman Nils Diaz of the Nuclear Regulatory Commission on 11/10/2001..."use of potassium iodide pills would have significantly reduced the incidence of thyroid cancer [during Chernobyl]".
"At last count, some 1,800 children in the former Soviet Union have developed thyroid cancer as a result of the [Chernobyl] accident. Almost all were very young-in the womb or under 2 years old-at the time of exposure. In adults, thyroid cancer is usually slow-growing, but in the Chernobyl children, it has proved to be aggressive. In more than two-thirds of cases, the malignancy has spread beyond the thyroid by the time of surgery. The disease has a long latency period, so thousands more cases are expected in coming decades". - in a letter from Peter G. Crane, former attorney for the Nuclear Regulatory Commission.
The American Thyroid Association
In November 2001, The American Thyroid Association endorsed the usage of Potassium Iodide for Radiation Emergencies. "The American Thyroid Association endorses the federal Nuclear Regulatory Commission's December 2000 action requiring states and the Federal Emergency Management Agency to look into having potassium iodide (KI) stockpiled and available for populations at risk for exposure to radioactive iodine from a nuclear emergency." - ATA November 30, 2001
"A radius of 20 miles [KI distribution around nuclear plants] is required by the Bioterrorism Act of 2002 (P.L.107-188) but this is much too restricted in light of the Chernobyl experience". - In response to the National Academy of Sciences Study of Strategies for KI Distribution and Administration.
"...both an expert committee of the National Academy of Sciences and the American Thyroid Association endorse the use of KI and have confidence in its safety..." - Letter from ATA President to Department of Health and Human Services, Washington, D.C.
"The seminal event that opened the world’s eyes to the importance of KI distribution was the 1986 Chornobyl nuclear accident, releasing a fallout cloud that spread radioactive iodine and other radionuclides throughout eastern and central Europe. Starting a few years later, infants and children who had been exposed to the fallout were diagnosed with an unusual and aggressive form of thyroid cancer, except in Poland where the government had distributed KI pills". From an ATA news summary titled, Experts Discuss Potassium Iodide Distribution in Case of Nuclear Incident (PDF document)
Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in congress, the executive branch and the courts. Their website covers are aspects of consumer protection including their statement on The NRC's Failure to Stockpile Potassium Iodide & Protect the Public Health and Safety. "For over 25 years, the use of blocking agents such as potassium iodide to prevent the accumulation of radioiodine in the thyroid gland has been known. The effectiveness of potassium iodide administration for thyroid gland protection in the event of releases of radioiodine was recognized by the National Council on Radiation Protection and Measurement in 1977. The Food and Drug Administration authorized use of potassium iodide as a thyroid-blocking agent for the general public in December 1978." - Public Citizen 2001
Union of Concerned Scientists
The Union of Concerned Scientists is a nonprofit partnership of scientists and citizens combining rigorous scientific analysis, innovative policy development and effective citizen advocacy to achieve practical environmental solutions. Read their release entitled, "Precaution for Nuclear Accident a Stitch in Time That Saves Way More Than Nine". Quote - "A January decision is expected by the Commissioner of Public Health for the State of Massachusetts on whether to recommend that potassium iodide be stockpiled to protect public health in event of an accident at a nuclear facility. The Union of Concerned Scientists joins many others from the environmental and medical communities in urging the Commissioner, Dr. Howard Koh, to recommend this crucial precaution." - Union of Concerned Scientists December 22, 1999
Consumer Package Insert
(Potassium Iodide Tablets USP, 130 mg)
Take potassium iodide (KI) only when public officials tell you. In a nuclear radiation
emergency, radioactive iodine could be released into the air. KI protects only the thyroid
gland from uptake of radioactive iodine. Therefore, KI should be used along with other
emergency measures that will be recommended to you by public officials.
If you are told to take this medicine, take it 1 time every 24 hours. Do not take it more
often. More KI will not help you. Too much KI may increase the chances of side effects.
Do not take this medicine if you know you are allergic to iodine (see SIDE EFFECTS
Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 130 mg of
IOSAT (Potassium iodide tablet, USP) is a thyroid blocking medicine that is used in a
nuclear radiation emergency only.
DIRECTIONS FOR USE
Use only as directed by public officials if a nuclear radiation emergency happens.
Adults over 18 years 1 tablet (whole or crushed) every day (130 mg)
Children over 12 years to 18 years 1 tablet (whole or crushed) every day (130 mg)
who weigh at least 150 pounds
Children over 12 years to 18 years 1/2 tablet (whole or crushed) or 4 teaspoonfuls
who weigh less than 150 pounds every day (65 mg)
Children over 3 years to 12 years 1/2 tablet (whole or crushed) or 4 teaspoonfuls
every day (65 mg)
Children over 1 month to 3 years 2 teaspoonfuls every day (32.5 mg)
Babies at birth to 1 month 1 teaspoonful every day (16.25 mg)
Tablets can be crushed and mixed in many liquids. To take the tablet in liquid solution, use
dosing directions under Making a Potassium Iodide Liquid Mixture.
Take KI every day (every 24 hours) as directed by public officials. Do not take more than 1 dose
in 24 hours. More will not help you. Too much medicine may increase the chances of side effects.
Making a Potassium Iodide Liquid Mixture:
1. Put one 130 mg KI tablet into a small bowl and grind it into a fine powder using the back of a metal
teaspoon against the inside of the bowl. The powder should not have any large pieces.
2. Add 4 teaspoonfuls of water to the crushed KI powder in the bowl and mix until the KI powder
is dissolved in the water.
3. Take the KI water mixture solution made in step 2 and mix it with 4 teaspoonfuls of low fat white or
chocolate milk, orange juice, flat soda, raspberry syrup, or infant formula.
4. The KI liquid mixture will keep for up to 7 days in the refrigerator. It is recommended that the KI liquid
mixtures be prepared weekly. Throw away unused portions.
The amount of KI (130 mg tablet) in the drink when mixed as described above is 16.25 mg per teaspoonful.
The number of teaspoonfuls of the drink to give your child depends on your child’s age as described in the
Child’s Age Give your child this amount in teaspoonfuls
Over 12 to 18 years old 4 teaspoonfuls will give you a 65 mg dose
who weigh less than 150 pounds
Over 3 to 12 years old 4 teaspoonfuls will give you a 65 mg dose
Over 1 month to 3 years old 2 teaspoonfuls will give you a 32.5 mg dose
Birth to 1 month 1 teaspoonful will give you a 16.25 mg dose
Note: This is the amount to give your child for one single dose in teaspoonfuls (not tablespoonfuls).
You should give your child one dose each day as recommended by the public officials.
Pregnant or breastfeeding women or babies under 1 month of age: Take as directed above
and call a doctor as soon as possible. Repeat dosing should be avoided. It is recommended that
thyroid function be checked in babies less than 1 month of age that take KI. Women who are
pregnant or breastfeeding should also be checked by a doctor if repeat dosing is necessary.
Although these precautions should be taken, the benefits of short-term use of KI to block uptake
of radioactive iodine by the thyroid gland far exceed its chances of side effects.
IOSAT Brochure 12/17/04 9:10 AM Page 1Patients with thyroid disease: If you have both a nodular thyroid condition such as
multinodular goiter with heart disease, you should not take KI. Patients with other thyroid
conditions may take KI as directed above, but call a doctor if you need to take KI for more than a
People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have
nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an
allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the
mouth or throat), call 911 or get medical care right away. In case of overdose, get medical help or call a Poison
Control Center right away.
HOW POTASSIUM IODIDE WORKS
Certain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods
like iodized salt or fish. The thyroid can “store” or hold only a certain amount of iodine.
In a nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed
or swallowed. It may enter the thyroid gland and damage it. The damage would probably not show itself for
years. Children are most likely to have thyroid damage. If you take KI, it will block or reduce the chances that
radioactive iodine will enter your thyroid gland.
WHO SHOULD NOT TAKE POTASSIUM IODIDE
People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic
vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the
chances of side effects to iodine.
HOW AND WHEN TO TAKE POTASSIUM IODIDE
KI should be taken as soon as possible after public officials tell you. If you are told to repeat the dose, you
should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you
because the thyroid can “hold” only certain amounts of iodine. Taking more than 1 dose per day will increase
the chances of side effects. The public officials will tell you how many days to take KI. You should take KI
until the chances of major exposure to radioactive iodine by breathing or swallowing stops.
Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are
Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever,
headache, metallic taste, and allergic reactions. Allergic reactions can include
• skin rashes such as hives
• swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet
• fever with joint pain
• trouble breathing, speaking or swallowing
• wheezing or shortness of breath
Get medical attention right away if you have trouble breathing, speaking or swallowing;
wheezing; shortness of breath; or swelling of the mouth, tongue or throat.
Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or
enlargement of the thyroid gland (goiter). Symptoms of an overactive thyroid gland may include an irregular
heart beat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1
month of age are more likely to get an underactive thyroid gland (hypothyroidism).
WHAT TO DO IF SIDE EFFECTS OCCUR
Stop taking KI and call a doctor if you have one or more of the following symptoms:
• swelling of the face, hands or feet
• fever and joint pain
• skin rash
Stop taking KI and get medical help right away if you have one or more of the following
• trouble breathing, speaking or swallowing
• shortness of breath or wheezing
• swelling of the lips, tongue or throat
• irregular heart beat or chest pain
Potassium iodide tablets, USP. Packages of 14 tablets. Each white, round, cross-scored tablet contains 130 mg
potassium iodide. Store at 20-25° C (68-77° F). Keep dry and foil intact.