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[Fwd: [aihaih-list] KI rescue for nuclear disasters]



This is just a FWD-FYI, not a debate topic.



Gary Greenberg wrote:



> Most of us remember learning that SSKI (super-saturated potassium

> iodide) or Logol's solution is protective against radioiodine

> absorption in situations of accidental exposure to radioiodine (eg

> after a release from a reactor or explosion).

>

> Since thyroid cancer is the most common malignancy and most important

> latent health effect following such ambient exposures, it seems useful

> to consider where supplies are kept and to know the protective dose.

>

> Surprisingly, this information was very difficult to find, and the

> table at the bottom of this (probably too) long message was not easily

> discovered. I hope that distributing this information never becomes

> useful, but that we as a profession can keep this possible

> intervention in mind (or in Palm!).

>

> Thanks,

> - Gary Greenberg

> --

> Gary N. Greenberg, MD MPH    Sysop / Moderator Occ-Env-Med-L MailList

> gary.greenberg@duke.edu     Duke Occupat, Environ, Int & Fam Medicine

> OEM-L Maillist Website:                      http://occhealthnews.net

>

> (¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯)

>

> Clinical Pharmacology 2000 Gold Standard Multimedia

>

> Indications:

>

> •hyperthyroidism?

> •iodine deficiency?

> •thyroid involution induction?

> •thyrotoxicosis?

>

> No mention of blocking absorption of radioiodine

>

> (¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯)

>

> Searching for "Lugol's Solution" or "Potassium Iodide"

>

> - No mention in Harrison's for disaster / accidental radioiodine

> protection

>

> - No mention in MD-Consult for disaster / accidental radioiodine

> protection, including the following texts:

>     > Washington Manual of Medical Therapeutics, 30th ed.

>     > Wilson: Williams Textbook of Endocrinology, 9th ed.

>     > Goldman: Cecil Textbook of Medicine, 21st ed.

>

> - No mention in WebMD Scientific American Medicine

>

> - No full-text online articles in OVID / Medline enhanced database

>

> (¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯)

>

> POISINDEX MANAGEMENTS (from MICROMEDEX)

>

> F. RADIONUCLIDE BLOCKERS

>

>  1. Ingestion of radionuclides mandates special

>  considerations. Following ingestion, there is usually a

>  variable period of time before absorption and uptake by

>  cells occurs. It is of utmost importance to determine the

>  specific radionuclide ingested, inhaled, or injected, as

>  therapy with chelating, diluting, or blocking agents is

>  determined by the radioelement(s) involved.

>

>  2. A blocking agent is a substance which saturates a tissue

>  with a nonradioactive element, thereby reducing the uptake

>  of the radionuclide. An example of this is potassium iodide

>  (Lugol's solution) which reduces the uptake of radioactive

>  iodine (I-131).

>

>  3. IODINE-131 -

>

>   a. LUGOL'S SOLUTION -

>

>    (1) Potassium iodide (Lugol's solution) reduces

>    radioactive iodine uptake by the thyroid by 90 percent if

>    given within 2 hours after exposure (Lincoln, 1976;

>    Jarrett, 1999).

>

>    (2) RECOMMENDATION - Mix 5 grams iodine and 10 grams

>    potassium iodide with water to a final amount of 100

>    milliliters. Give 100 milligrams, 2 to 3 drops in glass

>    of water. Alternatively, give 130 mg potassium iodide, or

>    0.8 milliliter Lugol's solution for adults

>    and adolescents (Jarrett, 1999).

>

> (¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯)

>

> Via FedWorld.gov

>

> - Analysis of Potassium Iodide (KI) Prophylaxis for the General Public

> in the Event of a Nuclear Accident. Performing Org.: Cohen (S.) and

> Associates, Inc., McLean, VA.; SCIENTECH, Inc., Rockville, MD.;

> Nuclear Regulatory Commission, Washington, DC. Office of Nuclear

> Regulatory Research.

>

> NTIS Order No: NUREG/CR-6310INZ. No summary is available on this web

> site for this publication.

>

> In Fed Register:

>

> SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its



> emergency planning regulations governing the domestic licensing of

> production and utilization facilities. The final rule requires that

> consideration be given to including potassium iodide (KI) as a

> protective measure for the general public that would supplement

> sheltering and evacuation. KI would help prevent thyroid cancers in

> the unlikely event of a major release of radioactivity from a nuclear

> power plant. The final rule responds to petitions for rulemaking (PRM

> 50-63 and PRM 50-63A) submitted by Mr. Peter G. Crane concerning the

> use of KI in emergency plans.

>

> EFFECTIVE DATES: April 19, 2001.

>

> On June 16, 1997, the NRC staff forwarded to the Commission a staff

> version of the FRPCC- proposed Policy Regarding Use of Potassium

> Iodide After a Severe Accident at a Nuclear Power Plant. In its SRM of

> June 30, 1997, the Commission endorsed the Federal offer to fund the

> purchase of KI for States. On June 26, 1998, the Commission directed

> that the FRPCC proposed Policy be modified to include a statement to

> the effect that State and local decision makers, provided with proper

> information, may find the use of KI as a protective supplement is

> reasonable and prudent for specific local conditions. As noted above,

> the Commission also reiterated its endorsement of the Federal offer to

> fund KI stockpiles for States. Subsequently, on April 22, 1999, the

> Commission directed the staff to amend the draft FRN on the Federal KI

> Policy to conform to the Commission decision on the petitions for

> rulemaking, and the decision not to fund State KI stockpiles.

>

> On April 29, 1999, the Director of FEMA, Mr. James Lee Witt, forwarded

> a letter to the Commission commenting on the issue of funding of

> stockpiles of KI for States. The letter objected to the Commission's

> ``unilateral'' decision on funding, and also noted ``FEMA has always

> opposed the notion that Federal regional stockpiles of KI would be

> effective [and believes that] regional stockpiles would complicate,

> not strengthen radiological emergency preparedness.'' FEMA believes

> that if a State opts to use KI as a supplemental protective measure,

> the NRC should provide the funds for such a purchase.

>

> The NRC responded to Mr. Witt's letter on June 15, 1999. This letter

> noted the Commission's decision not to fund state stockpiles of KI as

> well as the reasons underlying that decision. The letter also referred

> to the Commission's direction to ``the NRC staff to work with FEMA

> staff to establish and maintain regional KI stockpiles to be used in

> the event that local stockpiles prove to be insufficient, or when a

> state without a stockpile elects to use KI on an ad hoc basis in the

> case of a nuclear emergency.'' The letter expressed confidence that

> the staffs, working together would successfully resolve the KI supply

> issue. The status of the stockpile and funding issues are discussed

> later in this notice. NRC is working closely with the other Federal

> agencies to determine appropriate changes to the 1985 policy. A

> decision regarding policy changes will be reached after the conclusion

> of this rulemaking.

>

> (¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯`·.¸¸.·´¯)

>

> [Federal Register: January 4, 2001 (Volume 66, Number 3)]

> [Notices]

> [Page 801-802]

> >From the Federal Register Online via GPO Access [wais.access.gpo.gov]

> [DOCID:fr04ja01-65]

>

> -----------------------------------------------------------------------

>

> DEPARTMENT OF HEALTH AND HUMAN SERVICES

>

> Food and Drug Administration

> [Docket No. 00D-1681]

>

> Draft Guidance on Potassium Iodide as a Thyroid Blocking Agent in

> Radiation Emergencies; Availability

>

> AGENCY: Food and Drug Administration, HHS.

> ACTION: Notice.

>

> -----------------------------------------------------------------------

>

> SUMMARY: The Food and Drug Administration (FDA) is announcing the

> availability of a draft guidance entitled ``Potassium Iodide as a

> Thyroid Blocking Agent in Radiation Emergencies.'' This draft guidance

> updates a notice of availability entitled ``Potassium Iodide as a

> Thyroid-Blocking Agent In a Radiation Emergency: Final Recommendations

> On Use'' published in the Federal Register on June 29, 1982,

> concerning the prophylactic use of potassium iodide (KI) in the event

> of release of radioactive isotopes of iodine. In the draft guidance,

> FDA maintains its position that KI is a safe and effective means by

> which to prevent radioiodine uptake by the thyroid gland, under

> certain specified condition for use, and thus to obviate the risk of

> thyroid cancer in the event of a radiation emergency.

>

> DATES: February 5, 2001.

>

> ADDRESSES: Copies of this draft guidance are available on the Internet

> at http://www.fda.gov/cder/guidance/index.htm. Submit written requests

> for single copies of the draft guidance to the Drug Information Branch

> (HFD-210), Center for Drug Evaluation and Research, Food and Drug

> Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-

> addressed adhesive label to assist that office in processing your

> requests. Submit written comments on the draft guidance to the Dockets

> Management Branch (HFA-305), Food and Drug Administration, 5630

> Fishers Lane, rm. 1061, Rockville, MD 20852.

>

> FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Executive

> Operations (HFD-06), Center for Drug Evaluation and Research, Food and

> Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-

> 6779.

>

> SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

> draft guidance entitled ``Potassium Iodide as a Thyroid Blocking Agent

> in Radiation Emergencies.''

>

> The Federal Emergency Management Agency has established roles and

> responsibilities for Federal agencies in assisting State and local

> governments in their radiological emergency planning and preparedness

> activities. The Federal agencies, including the Department of Health

> and Human Services (DHHS), are expected to accomplish these roles and

> responsibilities as part of the Federal Radiological Preparedness

> Coordinating Committee. Among other responsibilities, the DHHS is to

> provide guidance on the use of radioprotective substances to reduce

> radiation doses to specific organs from the release into the

> environment of large quantities of radioactivity. FDA is specifically

> charged with providing guidance on the prophylactic use of KI in the

> event of release of radioactive isotopes of iodine.

>

> FDA is announcing the availability of a draft guidance that updates

> the notice of availability, ``Potassium Iodide as a Thyroid-Blocking

> Agent In a Radiation Emergency: Final Recommendations On Use,''

> published in the Federal Register of June 29, 1982 (47 FR 28158). In

> this draft guidance, FDA maintains its position 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 thus to lessen

> the risk of thyroid cancer in the event of a radiation emergency. In

> this draft guidance, FDA proposes lower radioactive exposure

> thresholds for KI prophylaxis as well as lower doses of KI for

> neonates, infants, and children than previously recommended. FDA's

> revised recommendations are in general accordance with those of the

> World Health Organization (WHO), as expressed in its ``Guidelines for

> Iodine Phrophylaxis Following Nuclear Accidents'' (1999), though they

> differ from those of the WHO in two areas.

>

> First, for the sake of logistical simplicity, FDA recommends the

> 65-milligram (mg) dose of KI for all school-age children while

> allowing for the full adult dose of 130 mg in adolescents approaching

> adult size. WHO recommends 130 mg KI for adults and adolescents (over

> 12 years of age). Second, FDA recommends that KI prophylaxis in those

> under age 19 and in pregnant or lactating women be triggered at a

> predicted thyroid radioiodine exposure of 5 centiGray (cGy), while WHO

> establishes 1 cGy as the threshold for intervention. FDA has concluded

> from the Chernobyl data that the most reliable evidence demonstrates a

> significant increase in risk of childhood thyroid cancer at exposures

> of 5 cGy or greater.

>

> The recommendations in the draft guidance were prepared by scientists

> from the Center for Drug Evaluation and Research and from the Center

> for Devices and Radiological Health of FDA in consultation with other

> governmental experts.

>

> This draft guidance is being issued consistent with FDA's good

> guidance practices (65 FR 56468, September 19, 2000). The draft

> guidance represents the agency's current thinking on use of potassium

> iodide as a thyroid blocking agent in radiation emergencies. It does

> not create or confer any rights for or on any person and does not

> operate to bind FDA or the public. An alternative approach may be used

> if such approach satisfies the requirements of the applicable statutes

> and regulations.

>

> Interested persons may submit to the Dockets Management Branch

> (address above) written comments on the draft guidance. Two copies of

> any comments are to be submitted, except that individuals may submit

> one copy. Comments are to be identified with the docket number found

> in brackets in the heading of this document. The draft guidance and

> received comments are available for public examination in the Dockets

> Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

>

> Dated: December 26, 2000.

> Margaret M. Dotzel,

> Associate Commissioner for Policy.

> [FR Doc. 01-189 Filed 1-3-01; 8:45 am]

> BILLING CODE 4160-01-F

>

> = - = - = - = - = - = - = - = - = - = - = - =

>

> http://www.fda.gov/cder/guidance/3698dft.htm#P177_18126

>

> Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies

>

> DRAFT GUIDANCE

>

> This guidance document is being distributed for comment purposes only.

>

> Comments and suggestions regarding this draft document should be

> submitted within 30 days of publication in the Federal Register of the

> notice announcing the availability of the draft guidance. Submit

> comments to Dockets Management Branch (HFA-305), Food and Drug

> Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All

> comments should be identified with the docket number listed in the

> notice of availability that publishes in the Federal Register.

>

> For questions regarding this draft document contact (CDER) Rose

> Cunningham 301-594-6779.

>

> U.S. Department of Health and Human Services

> Food and Drug Administration

> Center for Drug Evaluation and Research (CDER)

> December 2000

> Procedural

>

> Additional copies are available from:

>

> Office of Training and Communications

> Division of Communications Management

> Drug Information Branch, HFD-210

> 5600 Fishers Lane

> Rockville, MD 20857

> (Tel) 301-827-4573

>

> ...

> IV. CONCLUSIONS AND RECOMMENDATIONS

>

> A. Use of KI in radiation emergencies: rationale, effectiveness,

> safety

>

> The direct relationship between exposure to inhaled or ingested

> radioiodines and thyroid cancer risk, if ever in doubt, is firmly

> established in the aftermath of the 1986 Chernobyl accident. For the

> reasons discussed above, the Chernobyl data provide the most reliable

> information available to date on the relationship between internal

> thyroid radioactive dose and cancer risk. They suggest that the risk

> of thyroid cancer is inversely related 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 of KI as a specific blocker of thyroid radioiodine

> uptake is well-established (Sternthal et al., 1980) as are the doses

> necessary for blockade. 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 (of which no cases were

> reported in Poland among users after the Chernobyl accident), GI

> disturbances, and minor rashes. In addition, persons with known iodide

> sensitivity should avoid KI, as should individuals with dermatitis

> herpetiformis and hypocomplementemic vasculitis, extremely rare

> conditions associated with an increased risk of iodine

> hypersensitivity.

>

> Thyroidal side effects of stable iodine include iodide-induced

> thyrotoxicosis, which is more common in older people and in

> iodide-deficient areas and usually requires repeated doses of stable

> iodine. In addition, iodide goiter and hypothyroidism, potential side

> effects more common in iodine-sufficient areas, require chronic high

> doses of stable iodine (Rubery 1990). 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 percent (12/3214) of

> neonates treated with KI in Poland after Chernobyl has been without

> 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. Nevertheless, 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 KI 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 (Fisher,

> Calaciura).

>

> B.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

> recommends administration of KI to children aged 0-18 years and

> pregnant or lactating women in the event of a projected radiation dose

> to the thyroid of 5 cGy or greater. For adults up to 40 years of age,

> KI should be administered at a projected radiation dose of 10 cGy or

> greater. Adults over 40 need only take KI in the case of a projected

> large internal radiation dose to the thyroid (>500 cGy) to prevent

> hypothyroidism (see table).

>

> Threshold Thyroid Radioactive Exposures and Recommended Doses of KI

> for Different Risk Groups

>

> For the radiation produced by I-131, the radiation quality factor is

> approximately equal to 1, so that 1 cGy = 1 rem.

>

> Pop'n       Predicted    KI dose  # 130mg  # of 65mg  Lugol's

> Exposed     Thyroid      mg       tablets  tablets    solution

>             exposure(cGy)

> Adults

>     >40 yrs     >500     130       1       2        0.8 ml

>

> Adults

>     >18-40 yrs  >10      130       1       2        0.8 ml

>

> Pregnant or

> lactating women >5       130       1       2        0.8 ml

>

> Adolesc.

>     >12-18 yrs* >5       65        1/2     1        0.4 ml

>

> Children

>     >3-12 yrs   >5       65        1/2     1        0.4 ml

>

> >1 month-3 yrs  >5       32        1/4     1/2      0.2 ml

>

> birth-1 month    >5      16        1/8     1/4      0.1 ml

>

> * adolescents approaching adult size (> 70 kg) should receive the full

> adult dose (130 mg)

>

> [OEM: Lugol's sol'n dosing based on Poisondex conversion see above.

> -Mod]

>

> These FDA recommendations differ from those put forward in the World

> Health Organization (WHO) 1999 guidelines for iodine prophylaxis in

> two areas. WHO recommends the 130 mg dose of KI for adults and

> adolescents (over 12 years). For the sake of logistical simplicity in

> the dispensing and administration of KI to children, FDA recommends

> the 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

> predicted exposure to those up to 18 years of age and to pregnant or

> lactating women that will trigger KI prophylaxis. WHO recommends a 1

> cGy threshold for this group. 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, adheres 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 blockade

> of thyroid radioiodine uptake. Neonates ideally should receive the

> lowest dose (16 mg) of KI to minimize the risk of hypothyroidism

> during that critical phase of brain development (Calaciura et al.,

> 1995). KI from tablets (either whole or fractions) or as fresh

> saturated KI solution may be diluted in milk or water and the

> appropriate volume administered to babies. As stated above, we

> recommend that neonates (within the first month of 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

> (Fisher 2000; Calaciura et al., 1995).

>

> 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. Lactating females should be

> administered KI for their own protection, as for other young adults,

> potentially to reduce the radioiodine content of the breast milk, but

> not as a means to deliver KI to infants, who should get their KI

> directly. As for direct administration of KI, stable iodine as a

> component of breast milk may also pose a risk of hypothyroidism in

> nursing neonates. Therefore, if repeat dosing of the mother is

> necessary, the nursing neonate should be monitored as recommended

> above.

>

> The protective effect of KI lasts approximately 24 hours. For optimal

> prophylaxis, KI should therefore be dosed daily, until a risk of

> significant exposure to radioiodines by either inhalation or ingestion

> no longer exists. Individuals intolerant of KI at protective doses and

> pregnant and lactating women (in whom repeat administration of KI

> raises particular safety issues, see above) should be given priority

> with regard to other protective measures (i.e., sheltering,

> evacuation, and control of the food supply).

>

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