Assuntos
Antivirais/uso terapêutico , Ensaios Clínicos como Assunto , Ciclopentanos/uso terapêutico , Surtos de Doenças , Guanidinas/uso terapêutico , Vírus da Influenza A Subtipo H1N1 , Influenza Humana/tratamento farmacológico , Ácidos Carbocíclicos , Aprovação de Drogas , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for use in treating an infection due to a biological agent used intentionally. The terrorist attacks of 2001 involving anthrax underscore the imperative that safe and effective drugs to manage such infections be readily available in the United States. The approval of ciprofloxacin hydrochloride, which was made on the basis of a surrogate human marker of efficacy, made extensive use of data from an animal model of disease. This represents a new direction in the development of efficacy data in support of drug approval and facilitates the availability of those drugs for which there is an urgent need. This article presents the scientific data and regulatory mechanism that supported the approval of ciprofloxacin hydrochloride for management of postexposure of inhalational anthrax.
Assuntos
Antraz/tratamento farmacológico , Antibacterianos/uso terapêutico , Ciprofloxacina/uso terapêutico , Adulto , Animais , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Antibacterianos/farmacocinética , Bacillus anthracis , Pré-Escolar , Ciprofloxacina/administração & dosagem , Ciprofloxacina/efeitos adversos , Ciprofloxacina/farmacocinética , Modelos Animais de Doenças , Esquema de Medicação , Aprovação de Drogas , Humanos , Exposição por Inalação , Macaca mulatta , Esporos Bacterianos , Estados Unidos , United States Food and Drug AdministrationAssuntos
Antraz/tratamento farmacológico , Antibacterianos/uso terapêutico , Bioterrorismo , Infecções Respiratórias/tratamento farmacológico , Antraz/prevenção & controle , Antibioticoprofilaxia , Humanos , Infecções Respiratórias/prevenção & controle , Estados Unidos , United States Food and Drug AdministrationRESUMO
OBJECTIVE: To develop consensus-based recommendations for measures to be taken by medical and public health professionals if hemorrhagic fever viruses (HFVs) are used as biological weapons against a civilian population. PARTICIPANTS: The Working Group on Civilian Biodefense included 26 representatives from academic medical centers, public health, military services, governmental agencies, and other emergency management institutions. EVIDENCE: MEDLINE was searched from January 1966 to January 2002. Retrieved references, relevant material published prior to 1966, and additional sources identified by participants were reviewed. CONSENSUS PROCESS: Three formal drafts of the statement that synthesized information obtained in the evidence-gathering process were reviewed by the working group. Each draft incorporated comments and judgments of the members. All members approved the final draft. CONCLUSIONS: Weapons disseminating a number of HFVs could cause an outbreak of an undifferentiated febrile illness 2 to 21 days later, associated with clinical manifestations that could include rash, hemorrhagic diathesis, and shock. The mode of transmission and clinical course would vary depending on the specific pathogen. Diagnosis may be delayed given clinicians' unfamiliarity with these diseases, heterogeneous clinical presentation within an infected cohort, and lack of widely available diagnostic tests. Initiation of ribavirin therapy in the early phases of illness may be useful in treatment of some of these viruses, although extensive experience is lacking. There are no licensed vaccines to treat the diseases caused by HFVs.
