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Medical Countermeasures for Radiation Exposure and Related Injuries: Characterization of Medicines, FDA-Approval Status and Inclusion into the Strategic National Stockpile.

Singh VK, Romaine PL, Seed TM - Health Phys (2015)

Bottom Line: An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations.Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA).In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

View Article: PubMed Central - PubMed

Affiliation: *Radiation Countermeasures Program, Armed Forces Radiobiology Research Institute, Bethesda, MD; †Department of Radiation Biology, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; ‡Tech Micro Services, Bethesda, MD.

ABSTRACT
World events over the past decade have highlighted the threat of nuclear terrorism as well as an urgent need to develop radiation countermeasures for acute radiation exposures and subsequent bodily injuries. An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations. Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA). The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

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Related in: MedlinePlus

Promising radiation countermeasures under development. Currently there are seven radiation countermeasures having FDA-IND status: Entolimod/CBLB502, Ex-RAD, BIO 300, OrbeShield, HemaMax, 5‐Androstenediol (5‐AED), and Neupogen. G-CSF and GM-CSF are available in the SNS. Other countermeasures are under different stages of development. Among the promising countermeasures being developed are myeloid progenitors (CLT‐008), GT3, AEOL 10150, and amifostine. There are three countermeasures against internally deposited radionuclides: potassium iodide, Prussian blue, and Ca-/Zn-DTPA.
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fig1: Promising radiation countermeasures under development. Currently there are seven radiation countermeasures having FDA-IND status: Entolimod/CBLB502, Ex-RAD, BIO 300, OrbeShield, HemaMax, 5‐Androstenediol (5‐AED), and Neupogen. G-CSF and GM-CSF are available in the SNS. Other countermeasures are under different stages of development. Among the promising countermeasures being developed are myeloid progenitors (CLT‐008), GT3, AEOL 10150, and amifostine. There are three countermeasures against internally deposited radionuclides: potassium iodide, Prussian blue, and Ca-/Zn-DTPA.

Mentions: Medical countermeasures for radiation fall into three broad classes. Radioprotectors or radioprotectants are prophylactic agents that are administered before exposure to prevent radiation-induced cellular and molecular damage (Stone et al. 2004). Radiation mitigators are drugs administered shortly after irradiation that accelerate recovery or repair of radiation injury. Radiation therapeutics or treatments are agents given after overt symptoms appear to stimulate repair or regeneration. Numerous candidate radiation countermeasures (specifically radioprotectants and radiomitigators) have been identified and either have been or are currently being developed for FDA approval (Dumont et al. 2010; Koenig et al. 2005; Singh et al. 2013, 2012c). Radionuclide eliminators are drugs that discorporate or block absorption of internalized radionuclides. Several candidate radiation countermeasures under this category have been identified and/or approved by FDA (Fig. 1, Table 1). Radionuclide eliminators currently licensed or under investigation include potassium iodide (KI), Prussian blue (PB), and zinc/calcium diethylenetriamine pentaacetate (Ca- and Zn-DTPA). This limited list of potentially useful drugs is alarming, especially in terms of the sheer lack of options and the limited scope of amelioration of which each drug is capable.


Medical Countermeasures for Radiation Exposure and Related Injuries: Characterization of Medicines, FDA-Approval Status and Inclusion into the Strategic National Stockpile.

Singh VK, Romaine PL, Seed TM - Health Phys (2015)

Promising radiation countermeasures under development. Currently there are seven radiation countermeasures having FDA-IND status: Entolimod/CBLB502, Ex-RAD, BIO 300, OrbeShield, HemaMax, 5‐Androstenediol (5‐AED), and Neupogen. G-CSF and GM-CSF are available in the SNS. Other countermeasures are under different stages of development. Among the promising countermeasures being developed are myeloid progenitors (CLT‐008), GT3, AEOL 10150, and amifostine. There are three countermeasures against internally deposited radionuclides: potassium iodide, Prussian blue, and Ca-/Zn-DTPA.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4418776&req=5

fig1: Promising radiation countermeasures under development. Currently there are seven radiation countermeasures having FDA-IND status: Entolimod/CBLB502, Ex-RAD, BIO 300, OrbeShield, HemaMax, 5‐Androstenediol (5‐AED), and Neupogen. G-CSF and GM-CSF are available in the SNS. Other countermeasures are under different stages of development. Among the promising countermeasures being developed are myeloid progenitors (CLT‐008), GT3, AEOL 10150, and amifostine. There are three countermeasures against internally deposited radionuclides: potassium iodide, Prussian blue, and Ca-/Zn-DTPA.
Mentions: Medical countermeasures for radiation fall into three broad classes. Radioprotectors or radioprotectants are prophylactic agents that are administered before exposure to prevent radiation-induced cellular and molecular damage (Stone et al. 2004). Radiation mitigators are drugs administered shortly after irradiation that accelerate recovery or repair of radiation injury. Radiation therapeutics or treatments are agents given after overt symptoms appear to stimulate repair or regeneration. Numerous candidate radiation countermeasures (specifically radioprotectants and radiomitigators) have been identified and either have been or are currently being developed for FDA approval (Dumont et al. 2010; Koenig et al. 2005; Singh et al. 2013, 2012c). Radionuclide eliminators are drugs that discorporate or block absorption of internalized radionuclides. Several candidate radiation countermeasures under this category have been identified and/or approved by FDA (Fig. 1, Table 1). Radionuclide eliminators currently licensed or under investigation include potassium iodide (KI), Prussian blue (PB), and zinc/calcium diethylenetriamine pentaacetate (Ca- and Zn-DTPA). This limited list of potentially useful drugs is alarming, especially in terms of the sheer lack of options and the limited scope of amelioration of which each drug is capable.

Bottom Line: An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations.Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA).In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

View Article: PubMed Central - PubMed

Affiliation: *Radiation Countermeasures Program, Armed Forces Radiobiology Research Institute, Bethesda, MD; †Department of Radiation Biology, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; ‡Tech Micro Services, Bethesda, MD.

ABSTRACT
World events over the past decade have highlighted the threat of nuclear terrorism as well as an urgent need to develop radiation countermeasures for acute radiation exposures and subsequent bodily injuries. An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations. Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA). The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

Show MeSH
Related in: MedlinePlus