- FDA approved 65 mg. Potassium Iodide (KI) tablet
- For Radiation Emergency Purposes Only
- Cross-scored for Easy Breaking
- Protects Your Family From Nuclear Emergency
- GMP Manufactured
- Expiry Date: 02-2018
ThyroSafe is the only FDA approved 65 mg. Potassium Iodide (KI) tablet. It is used to protect your thyroid gland against radioactive iodine released during a nuclear emergency. It does this by flooding the thyroid with stable, safe iodine, which blocks the absorption of dangerous radioactive iodine. ThyroSafe is produced by Recipharm AB who has more than 20 years experience in manufacturing Potassium Iodide tablets. Each tablet of ThyroSafe has a convenient cross-score, making it easy to break for small children.
Recipharm has been supplying European countries with potassium iodide for many years. After the 9/11 disaster, an American division of Recipharm was established in the United States to bring ThyroSafe™ into America. Today, ThyroSafe™ is the only FDA approved potassium iodide tablet that comes in the child appropriate 65 milligram dosage.
What is the risk to human health during a radiation emergency?
During a nuclear emergency, radioactive iodine is released and is swallowed or inhaled by human beings. It will then be absorbed into the thyroid gland. Even very small amounts of radioactive iodine will eventually deliver a large radiation dose to thyroid cells resulting in various abnormalities later in life including loss of thyroid functions, nodules in the thyroid or thyroid cancer.
Children whose thyroids are especially active, are extremely susceptible to it. Four years after the Chernobyl nuclear accident, the observed cases of thyroid cancer among children aged 0-4 years at the time of the accident in Belarus and Ukraine exceeded the expected number of cases by 30-60 fold. During the ensuing years, in the most heavily affected areas, incidence of thyroid cancer is as much as 100-fold compared to pre-Chernobyl rates. However, in Poland, where over 18 million doses of Potassium Iodide (KI) were administered to 97% of the children, there has been no increase in thyroid cancer.
Why should we take ThyroSafe™ in a radiological accident?
The effectiveness of KI as a specific blocker of thyroid radioiodine uptake is well established. When administered in the recommended dose, the potassium iodide in ThyroSafe™ is absorbed by the thyroid gland, which will effectively saturate the gland in such a way that inhaled or ingested radioactive iodines will not be accumulated in the thyroid gland. Therefore the risk of thyroid cancer in individuals or populations is reduced.
How safe is ThyroSafe™?
As reported in the American Journal of Medicine (Volume 94, P.524-532, May, 1993) the incidence of side effects in Poland among the roughly 18 million who took KI after the Chernobyl accident is very small. Approximately 3% suffered some form of stomach upset (due, in part, to the fact that a liquid KI was used instead of a tablet), 1% had a mild skin rash, and 1% suffered other mild symptoms. 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 (preferring to suffer an allergic respiratory problem to the possibility of thyroid cancer.)
Should pregnant women take ThyroSafe™?
According to the FDA, pregnant women should be given 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 KI of pregnant women should be avoided.)
Who should not take ThyroSafe™ or have restricted use?
According to the FDA, persons with known iodine sensitivity should avoid ThyroSafe™, as should individuals with dermatitis herpetiformis and hypocomplementemic vasculitis, extremely rare conditions associated with an increased risk of iodine hypersensitivity. Individuals with multinodular goiter, Graves’ disease, and autoimmune thyroiditis should be treated with caution—especially if dosing extends beyond a few days.
Why are there 65 mgs. of Potassium Iodide in each tablet of ThyroSafe™?
ThyroSafe™ is the only FDA approved Potassium Iodide (KI) tablet with 65 mg. strength. The FDA Guideline suggests: “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.”
When should one take ThyroSafe™?
ThyroSafe™ should be taken as soon as possible after an alert from public health officials tell you. If health officials instruct you to repeat the dose, you should take one dose every 24 hours. Do not take any KI product unless instructed to do so by local health authorities.
How is ThyroSafe™ prepared for small children?
One of the major advantages of ThyroSafe™ over other Potassium Iodide products is that the ThyroSafe™ 65 mg. tablet has a cross-score, making it be easily broken into ½ or ¼ tablet to satisfy the graded dose requirement, as recommended by the FDA Guideline (see below).
Thyrosafe™ Tablets Daily
|Adults and children over 18 yrs.
|Children ages 3 through 18 yrs.
|Children over 1 month through 3 yrs.
|Children under 1 month
For those small children who cannot swallow the tablet with water, the required fraction of tablet should be ground into powder first and then dissolved in water or other preferable drink. If you have difficulty breaking ThyroSafe™ into ¼ tablet for a neonate, take ½ tablet and follow the above procedure. Then give half the drink volume to the neonate. For more information on treating infants, visit the U.S. FDA’s discussion of the topic at: http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm072261.htm.
Will delayed administration of ThyroSafe™ flush radioactive iodine out of the thyroid gland?
Radioactive iodine, once bound in the thyroid, cannot be flushed out by subsequent administration of nonradioactive iodine. Therefore, any delay in saturating your thyroid with ThyroSafe™ is a serious risk to be aggressively avoided, especially for your children. It is highly recommended that you should have a supply of ThyroSafe™ on hand now.
In case of a radiation emergency, and upon notification by local health authorities, children 1 month to 3 years of age take one-half tablet. Neonates under 1 month should take one-quarter tablet. The tablets are cross-scored for easy breaking.
Children aged 3 to 18 years take one tablet daily. Adults over 18 years of age take two tablets daily. Local health authorities will inform you how long to continue taking ThyroSafe™.
|Serving Size: See Above
|Servings Per Box: Varies
||Amount Per Tablet
|% Daily Value
|Potassium Iodide (KI)
|† Daily Value not established
Lactose, magnesium stearate, microcrystalline cullulose.
Store at 20-25°C (68-77°F).
Keep dry and foil intact. Protect from light.
Do not throw away consumer package insert.