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iOSAT Potassium Iodide is the first "Radiation Protective" or Thyroid Blocking" agent to be sold directly to the general public. Its active ingredient, 130 mg. of potassium iodide (KI), gives virtually complete protection from the most feared consequence of a nuclear accident - a meltdown and release of radioactive iodine into the environment. There are 14 130mg tablets in each package.
Radioactive iodine (primarily I-131) is a waste product of nuclear fission produced in reactors and bombs. Its potential impact on human health is staggering, and it could affect more people (perhaps far more people) than all other radioactive sources combined. US Nuclear Regulatory Commission (NRC) reports indicate that a major release could injure hundreds of thousands of people, and many believe that the government is underestimating the danger.
What makes I-131 so dangerous is that the body can not distinguish it from ordinary iodine. As a result, if it is accidentally swallowed (in contaminated food or water), or inhaled (it can remain in the atmosphere for days), it will be absorbed into the thyroid gland and will remain there long enough to slowly poison its victim. It can take 20 to 30 years, but eventually it can lead to cancer, thyroid damage, growth and birth defects, or death. Children, whose thyroids are especially active, are extremely susceptible to it.
But iOSAT™ protects against radioactive iodine by preventing its absorption by the thyroid gland. iOSAT™ saturates (blocks) the thyroid with stable iodine, "filling it to capacity". Once filled, the gland "turns off" its absorption mechanism, and it will remain off long enough for the radioactive iodine to disappear naturally. This method of protection is extremely safe and effective, and up to 99% of all radiation induced thyroid damage can be avoided by the use of iOSAT™.
The value of potassium iodide was demonstrated following the Chernobyl nuclear accident, where authorities began mass distribution (millions of doses) of KI 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 KI was not distributed, previously rare forms of juvenile thyroid cancer have begun appearing at epidemic rates, with over 11,000 cases reported by the year 2000.
But the radiation did not stop at the Soviet border. In Poland, 300 miles away, authorities watched as radioactive iodine levels began climbing. Soon, authorities felt they had no choice, and doctors ordered a protective dose for every child in the country. These efforts proved successful, and there has been no increase in thyroid cancer in Poland due to Chernobyl. Similar preventative measures took place in other areas throughout Europe, with similar success.
These programs succeeded because most European countries had long stockpiled KI for emergency use in the event of a nuclear accident or war. Planners, therefore, had access to the drug (which should be taken prior to exposure for maximum effectiveness) when it was needed. Unfortunately, similar mass stockpiles are not kept in the United States.
Who needs iOSAT™?
There are approximately 100 commercial nuclear plants in the United States, each with one or more reactors. It is estimated that a "Chernobyl-sized" accident could spread radioiodine for hundreds of miles around each. Many people (especially in the Northeast) live within the danger radius of multiple plants.
200 Mile Zones around US Nuclear Plants
Fortunately, while nuclear reactors contain numerous radioactive products, most of the danger can be isolated to iodine. This is because iodine is unique in that:
1. It is very abundant in a reactor,
2. It remains in the environment for as long as 60 days,
3. It is biologically active, and once absorbed stays in the body where it is concentrated in the thyroid, and
4. Under accident conditions it can form an aerosol which can be blown downwind for hundreds of miles
No other radioactive product shares these characteristics, which is why health professionals fear the release of radioactive iodine more than any other consequence of a reactor accident. Estimates suggest that 95% of all health effects in a nuclear accident would be thyroid related, and that the prompt use of KI could prevent almost all of the injuries that would otherwise occur (in areas more than a few miles away from the plant site).
Unfortunately, current safety regulations for America's nuclear plants are surprisingly unconcerned with the impact of iodine on the, literally, millions of people located more than a few miles from the reactor. Instead, emergency planning is essentially limited to a small "Emergency Planning Zone" (EPZ) of 5 to 10 miles around the plant, and is focused on evacuation of all people who might be exposed to radiation. There are virtually no plans in place to protect the much larger number of people located from 10 to 200 miles from the plant site, for whom evacuation is not feasible.
Yet, the potential for large casualties outside the EPZ is not unknown by authorities. According to figures provided by the US Nuclear Regulatory Commission (NRC), radioiodine could injure people located as far away as 200 miles from a reactor. If, for example, an accident were to occur at one of the Indian Point reactors (25 miles north of New York City), enough radioiodine could be released to potentially injure one person in every other household in northern New Jersey. In New York City, itself, from 25% to 40% of all adults would be expected to be injured, with children at twice the risk. At these levels, of course, casualties would number in the millions.
How safe is it?
Potassium iodide is extremely safe in the dosage provided by iOSAT™. Because it is widely used in other treatments, its effects are well known. Millions of KI tablets are consumed annually in the US with virtually negligible side effects. Calculations by the National Council on Radiation Protection suggest that the incidence of adverse reactions to the KI in iOSAT™ can be as low as 1 in 10 million, and often no more than a mild skin rash.
Because of the inherent safety of KI, the FDA allows iOSAT™ 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.
Who should not take iOSAT™?
The only people who should not take iOSAT™ are people with a specific allergy to iodide. Pregnant and nursing women, as well as infants, may take the drug. Parents should be aware that children and unborn are extremely susceptible to radioiodine poisoning. People taking other thyroid medicines may also take iOSAT™.
What's the dosage?
iOSAT™ should be stored in a dry, room-temperature environment, with the blister packages unopened until its use is directed by public health authorities in a radiation emergency. Then, one tablet per day should be taken for as long as directed by public health officials. Under this regimen, sufficient thyroid blocking will be achieved to insure protection even in the worst accident. Of course, anyone taking iOSAT™ should follow all instructions from the public health authorities, including evacuation if conditions are judged to warrant it.
1. Meets all FDA requirements for potassium iodide as a radiation protective, and is labeled and packaged in accordance with US government guidelines. Has demonstrated all quality controls and passed all FDA requirements for purity, quality, safety, efficacy.
2. Comes full strength (130 mg of potassium iodide per tablet) in accordance with FDA demands for complete thyroid blocking.
3. Contains no potassium iodate or other adulterants. Contains only pure potassium iodide as the active ingredient.
4. iOSAT™ [potassium iodide] is manufactured in the United States under strict FDA "GMP guidelines," and holds an approved "New Drug Application" (NDA).
5. iOSAT™[potassium iodide] was the first product of its kind (since 1982) and is the only product which can be purchased by local, state and federal governments. Is widely purchased by nuclear utilities.
6. iOSAT™[potassium iodide] offers unit dose packaging for maximum shelf-life and allows for individual tablet distribution without fear of loss of packaging integrity.
Proof of KI's safety was demonstrated beyond reasonable doubt following the Chernobyl accident. As reported in The American Journal of Medicine, (Volume 94, May, 1993), despite very high levels of public anxiety caused by the fear of radiation, the incidence of side effects in Poland among the roughly 18 million who took iodine was very small. Approximately 99.8% of those who took KI had no side effects whatsoever, with only a few recipients reporting a mild skin rash or stomach upset. Only 2 cases of more serious side effects were noted, and both of these occurred among people with known allergies to iodide who had been warned not to take KI -- but did so anyway.
Iosat Potassium Iodide Frequently Asked Questions
How many tablets are in each package?
There are 14 tablets in each package of iOSAT™, which will protect one adult for two weeks. Anyone remaining in a contaminated area for more than two weeks should consider the use of additional iOSAT™ tablets as directed by Public Health Officials.
What is the daily dosage required?
New FDA guidelines call for the daily administration of one iOSAT tablet (130 mg. of potassium iodide (KI)) for adults and children over 18 years old who weigh more that 150 pounds. Children from age 3 to 18 years old who weigh less than 150 pounds should take ½ tablet. Children from age one month to 3 years should take ¼ tablet. And infants less than one month old should take ¼ tablet. If necessary, children too young to take solid food or unable to swallow a tablet can take iOSAT™ dissolved in a liquid (such as chocolate milk) or in a soft food such as applesauce.
How long is the shelf life of potassium iodide?
iOSAT™ Tablets are FDA approved for seven years and should be stored unopened in a dry environment at room temperature.
How long does the protection last?
Each iOSAT™ Tablet provides 24 hours of protection.
How long has Anbex been in business?
Anbex was formed shortly after the Three Mile Island accident in 1979. The company received its NDA (the FDA approval to sell the product) in 1982 after FDA review of the product and its manufacturing process.
Does KI help prevent other cancers that might occur other places in the body?
iOSAT™ only protects against radioactive iodine which can injure the thyroid and cause thyroid cancer, thyroid nodules, and other thyroid problems. The product is essentially ineffective against other radioactive products. However, since radioactive iodine would probably be the cause of 90% to 95% of all "off-site" injuries in a power-plant accident, the protection provided by iOSAT™ is extremely valuable. (At Chernobyl, for example, thyroid cancer, which is now epidemic in some areas as a result of the accident, was the only health effect seen in areas more than a few miles from the plant.)
What is the US Government's position on providing KI to workers and the public in the event of another nuclear emergency?
The US Nuclear Regulatory Commission (NRC) does not dispute the safety or effectiveness of KI. In fact, they require nuclear power-plants to stockpile it to protect plant workers, and FEMA (Federal Emergency Management Agency) plans call for KI to protect those individuals who would be unable to be evacuated in a nuclear accident - especially those under the care of the government (such as prisoners or patients in government hospitals).
But the NRC is resisting the calls for a national stockpile of KI, claiming it is "unnecessary." As a result, the US remains the only major nuclear power that does not have a supply to protect its citizens. Recently, to counter the widespread criticism of this policy, the government announced it had established a "national stockpile" of KI. This news was welcomed by many in the scientific community. However, at a recent meeting, the NRC admitted that its operational "national stockpile" consisted of only 2500 tablets, not even enough for 200 people.
As a reaction to criticism by US medical groups and the World Health Organization, the NRC has announced it would make KI available (free of charge) to state or local governments desiring it. Again, this news was greeted with enthusiasm. However, following this announcement, the NRC "clarified" its position, and now says it will provide KI only to those people living in communities within the 10 mile "EPZ" (Emergency Planning Zone) surrounding nuclear plants. Given that most casualties in a nuclear accident would take place more than 50 miles from the plant (following Chernobyl, thousands of cases of childhood thyroid cancer developed hundreds of miles away), the current NRC position is probably of questionable value.
Why doesn't my iOSAT™ come with written instructions?
The iOSAT™ package comes with a Patient Product Inserted along with the tablets in a sealed package. This was designed so that the instructions would not become separated from the product in times of an emergency.
Here Comes Fallout!
(Now, What was it I was supposed to Take?)
By Chuck Fenwick
Director, Medical Corps, Courtesy of TACDA
What is the big deal about KIO3 or KI? You know it is for nuclear preparedness, but just why is it so important?
Of all the radioactive isotopes and radioactive particles that can come from a nuclear reaction, radioactive iodine 131 (I-131) poisoning is one of the most lethal. The good news is that damage to the thyroid from exposure to I-131 can be prevented. Keep in mind these facts about your thyroid:
1) Your thyroid runs on iodine.
2) Your thyroid is a pig.
3) Your thyroid is stupid.
Your thyroid runs on iodine and will absorb all it can until it is absolutely full. This fullness is called saturation or blockade. However, your thyroid does not know the difference between good iodine and bad iodine. Good iodine is taken up by the thyroid in the form of potassium iodate (KI03) or potassium iodide (KI). Bad iodine, I-131, is a radioisotope of iodine which is produced in nuclear reactions such as a bomb or nuclear power plant. I-131 is what we call a beta emitter and if you get it on your skin it will burn you in much the same way as when you get bad sunburn. It has a half-life of roughly 8 days (8.01 to 8.07). One of the reasons spent fuel rods are stored in pools of water for months at a time, is that they will be off-gassing I-131 for roughly 10 half-lives (approximately 80 days).
If you are caught unprotected and downwind from a nuclear reaction and the plume or cloud of fallout reaches you, your thyroid will absorb this bad iodine. You now have sunburn in your thyroid and it is not going to go away. Eventually that sunburn in your thyroid can give you cancer (the FDA doesn’t like me saying “will” give you cancer).
Now that your thyroid has absorbed the bad iodine, is there anything you can do to clean the thyroid out?
The answer is no. There are a few things that will help, but in reality you now have this radioactive sunburn in your thyroid and you are in big trouble. All of the good iodine or Prussian Blue or activated charcoal we can throw at the problem is not going to help. Depending on your age it will… uh.. may take you several months to several years to develop cancer of the thyroid. That is the bad news. The good news is coming up.
The Good News:
Iodine--including I-131 and the other iodine isotopes--are from the halogen group. They act like a gas, which combines with things such as soil or metal. In a plume they float along and when conditions are right they “plate out” and come down like microscopic rain where growing plants, animals, and humans absorb them. We may breathe, eat or drink I-131 and even absorb it through the skin. And yes, your pets are at risk too, as well as your livestock. In fact, it is best not to eat exposed plants or food animals for at least 90 days, and this includes eggs and milk. Remember, your thyroid doesn’t care if it is bad or good iodine, nor does it care where it comes from.
Let’s get back to the “I’m going to die” part. When taken for the proper length of time and in the proper amounts, KI03 and KI act as “thyroid blockers”. When the thyroid is filled to capacity with good iodine, the bad iodine is blocked from entering. If you had KIO3 or KI on hand and had taken it before the plume or cloud reached you, then your thyroid would have been about 99% saturated with good iodine. The bad iodine would then biologically slough from your body through natural bodily functions. The bad iodine will only affect those who haven’t prepared.
Will the government be able to provide KI or KIO3 to you after (or just before) exposure to fallout?
Maybe. If a power plant melts down or in a small terrorist attack, government officials may have time to get the iodine blockers to you. If it is a full-scale nuclear attack, however, members of the state and federal government will be too occupied with personal survival to help anyone except themselves. Keep in mind that a nuclear attack always produces an EMP (Electro Magnetic Pulse) and quite likely all electrical circuits will be destroyed or damaged. It will then be impossible to print or distribute any printed material through normal media processes. In fact, that new digital safe where you keep your family papers, guns, money and medicines will never work again, and if your KIO3 is in there, then your thyroid is in big trouble.
KIO3 versus KI:
Actually there is no versus. They are both thyroid blockers and both will blockade the thyroid. Both KI and KIO3 are FDA approved and inspected.
KIO3 is more heat tolerant than KI; therefore, KIO3 is used in most of the world’s iodized salt—not so the United States. When stored in a dark, cool place, KIO3 has a much longer shelf life than KI. Because it is so stable, Medical Corps stamps an 8 to 10 year shelf life on the label, and has given a lifetime replacement warranty on the product. If your KI03 has been damaged or is beyond the warranty date, send a picture of your bottle, and we will replace the 90-tablet bottle for $5.00, and the 200-tablet bottle for $10.
How much should you have on hand?
First and foremost, you need to have a several weeks’ supply of KI or KIO3 on hand in storage, now. If we have a nuclear event, the chances of you getting it after the event are remote to nonexistent. Another point to consider: If we have one nuclear event we will most likely have others over the next several days. That is the reason we produce multi-dose bottles. We had to ask ourselves, "How much is enough?"
How do you Take KI and KIO3?
KIO3 can be taken in tablet form or sprinkled on food or dissolved in drinks. It is not bitter and children won't throw it up--which is the point. However, taking KIO3 on an empty stomach feels like taking an aspirin on an empty stomach so take it with food or water. If food or water is not handy then by all means don't delay--just swallow or chew up the proper dose. KI, on the other hand, is terribly bitter and the taste must be disguised. This from the FDA on disguising the bitter taste of KI: The mixture of potassium iodide with raspberry syrup disguises the taste of potassium iodide best. The mixtures of potassium iodide with low fat chocolate milk, orange juice, and flat soda (for example, cola) generally have an acceptable taste. Low fat white milk and water did not hide the salty taste of potassium iodide.
When should you take a thyroid blocker?
I'm supposed to say that the authorities will tell you when to take the KIO3 or KI, but if there is an EMP it will be impossible for them to relay this information, and most likely the authorities will either be in a shelter or dead--so you really are on your own. A gas mask will not do the job properly. You would have to live, eat, drink and sleep in the mask for many days. Also, human skin will absorb radioactive iodine even if you do wear a mask. The only way to completely avoid I-131 is to stay in a self-contained blast shelter that has a proper air filtration system. Thyroid blockers are most effective if taken 8 to 12 hours before exposure. They can be started 8 to 12 hours after exposure with fairly good results, but the earlier the better, as any amount of radioactive iodine is bad for your thyroid.
Caution! KIO3 in tablet form is for nuclear emergencies, only, and is not a supplement for thyroid health. You want your thyroid to function normally during peacetime and the amount of iodine you receive in your food and salt should be adequate for normal thyroid function. Do not take a thyroid blocker unless you expect an imminent exposure to radioactive fallout. Medical Corps' KIO3 will block the thyroid from working, which is exactly what you want to happen during a nuclear emergency. The directions are on the bottle and are very important.
How long should you take a thyroid blocker?
You will need to take your KIO3 or KI for 3 to 14 days depending on the event. For a period of 80 days after the last known nuclear event, do not drink the milk from cows or goats and eat only canned foods. Small babies should not take a thyroid blocker for longer than 3 days unless absolutely necessary. This means a baby in the womb, too! If pregnant, do not take a thyroid blocker for more than 3 days or nurse your baby while taking the blocker. If babies block their thyroid for longer than 3 days then a doctor may need to give them a thyroid stimulating hormone (TSH). If your thyroid has been surgically removed then you do not need to take a thyroid blocker.
Read the label for proper dosing. KIO3 comes in 170mg tablets or 85mg tablets. KI comes in 130mg tablets or 65mg tablets so the dosing on the bottle will tell you how much to take and how often.
In conclusion: Buy your KI or KIO3 now so you can concentrate on other things like food, water, shelter and education--especially education. The old civil defense motto was: Knowledge Replaces Fear.
Chuck Fenwick, Director, Medical Corps
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