1. What is the thyroid gland and what does it do?
The thyroid is a small gland located at the base of the throat. It has the only cells in the body capable of absorbing iodine. A functioning thyroid gland concentrates iodine from a person’s blood, obtained through food, iodized salt, or supplements, and combines that iodine with the amino acid tyrosine. The thyroid then converts the iodine/tyrosine combination into the hormones that control a person’s metabolism and growth rate.

2. What is ThyroSafe™?
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 Recip AB, Sweden, 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 into four pieces for small children.

3. 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.

4. 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.

5. 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.)

6. Has there been an FDA extension of the expiration dates of ThyroSafe™?
The FDA has approved an extension of the expiration dating period to 72 months according to ANDA 76-350/S-007. The new expiration dates are:

7. 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.

8. 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.

9. 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.”

10. 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.

11. 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).

Age Group	KI Dose	ThyroSafe™ 65 mg. tablets
Children ages 3 through 18 yrs.	65 mg	1
Children over 1 month through 3 years	32 mg	½
Children under 1 month	16 mg	¼