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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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