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HEALTH TREASURES KI - KIO3 Pills

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Rad Block™
Potassium Iodide
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Nuclear Radiation Protection
Rad Block Product Insert
Thyroid Cancers in the Aftermath of Chemobyl
The Chernobyl reactor accident resulted in massive releases of 131I and other radioiodines. Beginning approximately 4 years after the accident, a sharp increase in the incidence cf thyroid cancer among children and adolescents in Belarus and Ukraine (areas covered by the radioactive plume) was observed. In some regions, for the first 4 years of this striking increase, observed cases of thyroid cancer among children aged 0 through 4 years at the time of the accident exceeded expected number of cases by 30- to 60-foId. During the ensuing years, in the most heavily affected areas, incidence is as much as 100-fold compared to pre-Chernobyl rates. The majority of cases occurred in children who apparently received less than 30 cGy to the thyroid. A few cases ocurred In children exposed to estimate doses of < 1 cGy; however, the uncertainty of these estimates confounded by medical radiation exposure leaves doubt as to the causal role of these doses of radioiodine.

We have concluded that the best dose-response information from Chernobyl shows a marked increase in risk of thyroid cancer in children with exposures of 5 cGy or greater. Among children born more than nine months after the accident in areas traversed by the radioactive plume the incidence of thyroid cancer has not exceeded preaccident rates, consistent with the short half-life of 131I.

Safety: The use of KI In Poland after the Chemobyl accident provides us with useful information regarding its safety and tolerability in the general population. Approximately 10.5 million children under age 16 art 7 million adults received at least one dose of KI. Of note, among newborns receiving single doses of 15 mg KI, 0.37 percent (12 of 3214) showed transient increases in TSH (thyroid simulating hormone) and decreases in FT4 (free thyroxine). The side effects among adults and children were generally mild and not clinically significant. Side effects included gastrointestinal distress, which was reported more frequently in children (up to 2 percent, felt to be due to bad taste of SSKI solution) and rash (about 1 percent in children and adults). Two allergic reactions were observed in adults with known iodine sensitivity.

Use of Kl in Radiation Emergencies: Rationale, Effectiveness, Safety: For the reasons discussed above, the Chernobyl data provide the most reliable: informatbn available to date on the relationship between internal thyroid radioactive dose and cancer risk. They suggest that the risk cf thyroid cancer is inversely relate to age, and that, especially in young children, it may accrue at very low levels of radioiodine exposure. We have relied on the Chernobyl data to formulate our specific recommendations below.

The effectiveness cf KI as a specific blocker of thyroid radioiodine uptake is well established as are the doses necessary for blocking uptake. As such, it is reasonable to conclude that KI will likewise be effective in reducing the risk of thyroid cancer in individuals or populations at risk for inhalation or ingestion of radioiodines.

Short term administration of KI at thyroid blocking doses is safe and, in general, more so in children than adults. The risks of stable iodine administration include sialadenitis (an inflammation of the salivary gland, of which no cases were reported in Poland among users after the Chemobyl accident), gastrointestinal disturbance, allergic reactions and minor rashes. In addition, persons with known iodine sensitivity should avoid KI, as should individuals with dermatitis herpetiformis and hypocomplementemic valsculitis, extremely rare conditions associated with an increased risk cf iodine hypersensitivity.

Thyroidal side effects of stable iodine include iodine-induced thyrotoxicosis, which is more common in older people and in iodine deficient areas but usually requires repeated doses of stable iodine. In addition, iodide goiter and hypothyroidism are potential side effects more common in iodine defficient areas, but they require chronic high doses of stable iodine. In light of the preceding, individuals with multinodular goiter, Graves' disease, and autoimmune thyroiditis should be treated with caution, especially if dosing extends beyond a few days. The vast majority of such individuals will be adults.

The transient hypothyroidism observed in 0.37 percept (12 of 3214) of neonates treated with KI in Poland after Chernobyl has been without reported sequelae to date. There is no question that the benefits of KI treatment to reduce the risk of thyroid cancer outweigh the risks of such treatment in neonates. Nonetheless, in light of the potential consequences of even transient hypothyroidism for intellectual development, we recommend that neonates (within the first month of life) treated with Kl be monitored for this effect by measurement of TSH (and FT4, if indicated) and that thyroid hormone therapy be instituted in cases in which hypothyroidism develops.

KI Use in Radiation Emergencies: Treatment Recommendations: After careful review of the data from Chernobyl relating estimated thyroid radiation dose and cancer risk in exposed children, FDA is revising its recommendation for administration of KI based, on age, predicted thyroid exposure, and pregnancy and lactation status (see Table).

The protective effect if KI lasts approximately 24 hours. For optimal prophylaxis, KI should therefore be dosed daily, until the risk of significant exposure to radioiodines by either inhalation or ingestion no longer exists. Individuals intolerant of KI at protective doses, and neonates, pregnant and lactating women (in whom repeat administration of Kl raises particular safety issues, see below) should be give priority with regard to other protective measures (i.e., sheltering, evacuation, and control of the food supply).

Note that adults over 40 need take KI only in the case of a projected large internal radiation dose to the thyroid (>500 cGy) to prevent hypothyroidism.

These recommendations are meant to provide states and local authorities as well as other agencies with the most current guidance on safe and effective use of KI to reduce thyroidal radioiodine exposure and thus the risk of thyroid cancer. FDA recognizes that, in the event of an emergency, some or all of the specific dosing recommendations may be very difficult to carry out given their complexity and the logistics of implementation of a program of KI distribution. The recommendations should therefore be interpreted with flexibility as necessary to allow optimally effective and safe dosing given the exigencies of any particular emergency situation. In this context, we offer the following critical general guidance: across populations at risk for radioiodine exposure, the overall benefits of KI far exceed the risks of overdosing, especially in children, though we continue to emphasize particular attention to dose in infants.

These FDA recommendations differ from those put forward in the World Health Organization (WHO) 1999 guidelines for iodine prophylaxis in two ways. WHO recommends a 130-mg dose of Kl for adults and adolescents (over 12 years). 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. The other difference lies in the threshold for predicts exposure cf those up to 18 years of age and of pregnant or lactating women that should trigger K1 prophylaxis. WHO recommends a threshold of 1 cGy for these two groups. As stated earlier, FDA has concluded from the Chernobyl data that the most reliable evidence supports a significant increase in the risk of childhood thyroid cancer at exposures of 5 cGy or greater. The downward KI dose adjustment by age group, based on body size considerations, adhere to the principle of minimum effective dose. the recommended standard dose of KI for all school-age children is the same (65 mg). However, adolescents approaching adult size (i.e., >70 kg) should receive the full adult dose (130 mg) for maximal block of thyroid radioiodine uptake. Neonates ideally should recieve the lowest dose (16 mg) of K1. repeat dosing of KI should be avoided in the neonate to minimize the risk of hypothyroidism during that critical phase of brain development. KI from tablets (either whole or fractions) or as fresh saturated KI solution may be diluted in milk, formula, or water and the appropriate volume administered to babies. As stated above, we recommended that neonates (within the first month cf life) treated with KI be monitored for the potential development of hypothyroidism by measurement of TSH (and FT4, if indicated) and that thyroid hormone therapy be instituted in cases in which hypothyroidism develops. Pregnant woman should be given Kl 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 Kl of pregnant women should be avoided. Lactating females should be administers KI for their own protection , as for other young adults, and potentially to reduce the radioiodine content of the breast milk, but not as a means to deliver Kl to infants who should get their KI directly. As for direct administration of KI, stable Iodine as a component of break milk may also pose a risk of hypothyroidism in nursing neonates. Ther:fore, repeat dosing with Kl should be avoided in the lactating mother, except during continuing severe contamination. If repeat dosing of the mother is necessary, the nursing neonate should be mentored as recommended above.

ADDITIONAL CONSIDERATIONS lN PROPHYLAXIS AGAINST THYROID RADIOIODINE EXPOSURE: Certain principles should guide emergency planning and implementation cf Kl prophylaxis in the event of a radiation emergency, After the Chemobyl accident , across the affected populations , thyroid radiation exposures ocurred largely due to consumption of contaminated fresh cow's milk (this contamination was the result of milk cows grazing on fields affected by radioactive fallout) and to a much lesser extent by consumption of contaminated vegetables. In this or similar accidents, for those residing in the immediate area of the accident or otherwise directly exposed to the radioactive plume, inhalation of radioiodines may be a significant contributor to individual and population exposures. As a practical matter, it may not be possible to assess the risk of thyroid exposure from inhaled radioiodines at the time of the emergency. The risk depends on factors such as the magnitude and rate of the radioactive release, wind direction and other atmospheric contains and thus may affect people both near to and far from the accident site. For optimal protection against inhaled radioiodines, KI should be administered before or immdiately coincident with passage of the radioactive cloud, though KI may still have a substantial protective effect even if taken 3 or 4 hours after exposure. Furthermore, if the release of radioiodines into the atmosphere is protracted , then, of course, even delayed administration may reap benefits by reducing, if incompletely, the total radiation dose to the thyroid.

Prevention of thyroid uptake of ingests radioiodines, once the plume has passed and radiation protection measure (including KI) are in place, is best accomplished by food control measures and not by repeated administration of KI. Because of radioactive decay, grain products and canned milk or vegetables from sources affected by radioactive fallout, if stored for weeks to months after production, pose no radiation risk. Thus, late KI prophylaxis at the time of consumption is not required. As time is of the essence in optimal prophylaxis with Kl, timely administration to the public is a critical consideration in planning the emergency response to a radiation accident and requires a ready supply of Kl. State and local governments choosing to incorporate KI into their emergency response plans may consider the option of predistribution of KI to those individuals who do not have a medical condition precluding its use.

SUMMARY: FDA maintains that KI is a safe and effective means by which to prevent radioiodine uptake by the thyroid gland, under certain specified conditions of use, and thereby obviate the risk cf thyroid cancer in the event of a radiation emergency. Based upon review of the literature, we have proposed lower radioactive exposure thresholds for KI prophylaxis as well as lower doses of Kl for neonates, infants, and children than we recommended in 1982. As in our 1982 notice in the Federal Register FDA continues to recommend that radiation emergency response plans Include provisions, in the event of a radiation emergency, for informing the public about the magnitude of the radiation hazard, about the manner of use of KI and its potential benefits and risks, and for medical contact, reporting , and assistance systems. FDA also emphasizes the emergency response plans and any systems for ensuring availability of KI to the public should recognize the critical importance of KI administration in advance of exposure to radioiodine. As in the past, FDA continues to work in an ongoing fashion with manufacturers of KI to ensure that high-quality, safe, and effective KI products are available for purchase by consumers as well as by state and local governments wishing to establish stores for emergency distribution. Kl provides protection only for the thyroid from radioiodines. It has no impact on the uptake by the body of other radioactive materials and provides no protection against external irradiation of any kind. FDA emphasizes that the use of KI should be as an adjunct to evacuation (itself not always feasible), sheltering, and control of foodstuffs." (End of FDA Guidelines extracts)

DIRECTIONS FOR USE: Use as directed by a physician and as directed by public health authorities. See above for FDA use guidelines.

STORAGE and SHELF-LIFE: Store at controlled room temperature between 15 degrees and 30 degrees C (59F to 86 F) and avoid excessive humidity. Keep bottle tightly closed. Potassium lodide, although required by the FDA to be labeled with a 3 year shelf-life at this time with Rad Block K1 TM should be efeective for decades if store properly. The product will remain effective even after opened, if resealed and stored as suggested.

DESCRIPTION: Each Rad Block KI tm tablet contains 65 MG of Potassium Iodide that yields 50 MG of ingestible iodine.

WHAT T0 D0 IF SIDE EFFECTS OCCUR : If the side effects are severe or if you have an allergic reaction, stop taking Potassium Iodide. Then, if possible, call a doctor or public health authority for instructions.

HOW SUPPLIED: Rad Block K1 TM Tablets (Potassium iodide Tablets, U.S.P.): bottles of 56 and 200 tablets. Each light yellow colored, round, scored tablet contains 65 MG Potassium iodide. the light yellow surface is due to a color coating to prevent any bitter taste (if you break the pill open, it will be white inside).Potassium Iodide (KI), as used In Rad Block KI TM, ls recommended by the WHO over products with Potassium Iodate (KI03) since KI03 can cause greater intestinal irritation, Rad Block KI TM, Is manufactured In a facility licenced as an over-the-counter drug manufacturer (federal and state) and conforms to aIl FDA guidelines for manufacture, labeling compliance and federal registration for NDC.
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