FAQs

A small gland located at the base of the throat, the thyroid contains the only cells in the human body capable of absorbing and storing iodine. When optimally functioning, it concentrates iodine from a person’s blood—obtained through food or iodized salt—and combines it with the amino acid, Tyrosine. This is then converted into the hormones that control a person’s metabolism and growth rate.

Manufactured by Astrea Fontaine SAS, France, who has more than 20 years experience in manufacturing Potassium Iodide tablets. Thyrosafe was developed to protect the thyroid against radioactive iodine released during a nuclear emergency.

During a nuclear emergency, radioactive iodine is released into the air. Once swallowed or inhaled, it is then absorbed into the thyroid gland. Even the smallest amount of radioactive iodine can result in abnormalities later in life, including but not limited to: loss of thyroid functions, nodules in the thyroid, or thyroid cancer. It is important to note that children are extremely susceptible to these conditions due to their especially active thyroids.

For more information on Potassium Iodide from the FDA, visit https://www.fda.gov/drugs/bioterrorism-and-drug-preparedness/frequently-asked-questions-potassium-iodide-ki#Can%20KI%20be%20used

ThyroSafe is a 65 mg KI Tablet that is FDA approved to help prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency.

As reported in the American Journal of Medicine (Volume 94, P.524-532, May, 1993), side effects among the roughly 18 million individuals who took Potassium Iodide (KI) after the Chernobyl accident were minimal. Approximately 3% suffered some form of upset stomach (due, in part, to a liquid KI being used instead of a tablet); 1% developed a mild skin rash; and 1% suffered other mild symptoms. Only 2 cases of more serious side effects were ever noted, and both occurred among people with known allergies to iodide.

According to the FDA, pregnant women should be given potassium iodide (KI) for their own protection and for that of the fetus as iodine (whether stable or radioactive) can readily cross the placenta. However, because of the risk of blocking fetal thyroid function with excess stable iodine, repeat dosing of KI should be avoided.

According to the FDA, individuals 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 an individual is allergic or hypersensitive to iodine. Individuals 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.

ThyroSafe should be ingested as soon as possible following an alert from public health officials. If health officials instruct you to repeat the dose, you should take one dose every 24 hours. Do not take any other potassium iodide (KI) products unless instructed to do so by authorities.

The FDA Guideline suggests, “For the sake of logistical simplicity in the dispensing and administration of KI to children, we recommend a 65 mg dose as standard for all school-age children, while allowing for the adult dose (130 mg, 2 x 65 mg.) in adolescents approaching adult size.

One of the major advantages of ThyroSafe is our standard cross-score, which makes it easy to break 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 TABLET
CHILDREN OVER 1 MONTH THROUGH 3 YRS	32 MG	1/2 TABLET

For small children who cannot swallow the tablet with water, the required fraction of tablet should be ground into a powder and then dissolved in water or other preferable drink. For more information on treating infants, visit the U.S. FDA’s discussion of the topic at:

Review the FDA Guidance

Once it has penetrated the thyroid, radioactive iodine cannot be flushed out by a subsequent administration of nonradioactive iodine. Therefore, any delay in utilizing ThyroSafe is a serious risk, especially for children.