In December 2001, the Food and Drug Administration (FDA) issued a final Guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies…

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The objective of the document is to provide guidance to other agencies and state and local governments regarding the safe and effective use of potassium iodide (KI) as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment.

1. What is radioactive iodine? One of the most dreaded consequences of a nuclear reactor accident or nuclear bomb is the release of a radioactive iodine (I-131) plume into the environment. This is especially dangerous because 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.

2. What is Potassium Iodide? (abbreviation is KI) Potassium Iodide (KI) has been recommended for over a decade by health officials worldwide to prevent thyroid cancer in people who are exposed to radioactive iodides caused by nuclear reactor accidents and nuclear bombs. KI protects you against radioactive iodine by preventing absorption by the thyroid gland, the only organ which has the ability to absorb iodine.

3. Is a prescription needed for this? NO. Due to 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.

4. How much should I buy? We recommended one IOSAT pack per person for storing at home. Each IOSAT pack has 14-130mg tablets.  This is 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?

5. Can I give it to my child easily? 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. Infants and small children cannot swallow tablets, and the amount of potassium iodide in a tablet will be too high for children less than 4 years of age; they would need ¼ or ½ a tablet. Since potassium iodide dissolved in water may be too salty to drink, the Food and Drug Administration (FDA) is providing parents or caregivers with instructions on how to mix the potassium iodide tablets, per age, with a food or a drink to disguise the taste so infants and small children will take the medicine in an emergency.

·         Low fat milk, plain or chocolate

·         Orange juice

·         Flat Soda (For example, cola)

For specific instructions, see: www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm072248.htm

6. 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. 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 radioioactive 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.

FDA guidelines:

 1.  What does potassium iodide (KI) do? 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 radioactive iodine. KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine.

 2.  Can potassium iodide (KI) be used to protect against radiation from bombs other than radioactive iodine? Potassium iodide ( KI) works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.

 
3.  Who really needs to take potassium iodide (KI) after nuclear radiation release? 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.  Finally, anyone over 40 should be treated with KI only if the predicted exposure is high enough to destroy the thyroid and induce lifelong hypothyroidism (thyroid deficiency).

4.  What potassium iodide (KI) products are currently available? As of January 2005, only three products, including IOSAT, marketed by Sam Andy, are FDA approved KI products. Please be aware that only the KI products approved by FDA may be legally marketed in the United States.

 
5.  How are these products available? In addition to distributing to state, local and federal agencies, Anbex, Inc., has made IOSAT Tablets (130 mg) available to the general public via Sam Andy.

6. What dosages of potassium iodide (KI) should be taken for specific exposure levels? For specific dosages for thyroid blocking, see the package insert.

7. How long should potassium iodide (KI) be taken? ince 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. 

8. Who should not take potassium iodide (KI) or have restricted use?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. A seafood or shellfish allergy does not necessarily mean that you are allergic or hypersensitive to iodine. People with nodular thyroid with heart disease should not take KI. Individuals with multinodular goiter, Graves' disease, and autoimmune thyroiditis should be treated with caution -- especially if dosing extends beyond a few days. If you are not sure if you should take KI, consult your healthcare professional.

 9.  What are the side effects ? Side effects are unlikely when KI is used at the recommended dose and for a short time. The following are possible side effects: 

·         Skin rashes

·         Swelling of the salivary glands

·         “Iodism” (metallic taste, burning mouth and throat, sore teeth and gums, symptoms of a head cold, and sometimes upset stomach and diarrhea)

·         An allergic reaction can have more serious symptoms. These include fever and joint pains; swelling of parts of the body (face, lips, tongue, throat, hands, or feet); trouble breathing, speaking, or swallowing; wheezing or shortness of breath. Severe shortness of breath requires immediate medical attention.

10.  Should I check with my doctor first? Potassium iodide (KI) is available over-the-counter (OTC).  However, if you have any health concerns or questions, you should check with your doctor.

 
11.  As a doctor, should I be recommending potassium iodide (KI) for my patients who request it? As with any drug, physicians should understand the risks and benefits of KI before recommending it or prescribing it to patients. The recommendations for intervention are based on categories of risk for thyroid cancer, with the young prioritized because of increased sensitivity to the carcinogenic effects of radioiodine.

12.  Should I go out and buy potassium iodide (KI) to keep on hand? 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.

To be on the safe side, in case authorities either don’t have or can’t get KI to you in a timely fashion, we recommend you have your OWN (a minimum) 14-day supply on hand both at home and / or in your vehicle.

13.  How do I know that potassium iodide (KI) will be available in case of an emergency? FDA will continue to work with interested pharmaceutical manufacturers to assure that high quality, safe, and effective KI products are available for purchase by consumers, by state and local authorities, and by federal government agencies electing to do so.