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1.
Ann Pharmacother ; 47(7-8): 1064-8, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23715069

RESUMEN

OBJECTIVE: To determine whether concomitant administration of zoster vaccine and polysaccharide pneumococcal-23 vaccine (PPV23) provides sufficient protection against herpes zoster infections. DATA SOURCES: Literature was retrieved through the Centers for Disease Control and Prevention (CDC) website, PubMed (inception-February 2013), and Scopus (inception-February 2013) using the key words herpes zoster, pneumococcal, vaccine, concomitant, simultaneous administration, Pneumovax, Zostavax, and barriers. In addition, reference citations from publications were used. STUDY SELECTION AND DATA EXTRACTION: All English-language articles identified from the data sources were evaluated. Two studies evaluating concomitant and nonconcomitant administration of zoster vaccine and PPV23 were included. DATA SYNTHESIS: Current product labeling recommends a 4-week interval between zoster vaccine and PPV23 administration; however, the Food and Drug Administration (FDA) and the CDC promote concomitant administration to prevent a missed opportunity to vaccinate. This has caused confusion among health care professionals regarding the appropriate timing of these vaccines. A randomized trial that evaluated the immunogenicity of zoster vaccine and PPV23 given together versus separated by at least 4 weeks demonstrated that the varicella zoster virus (VZV) antibody levels of concomitant versus nonconcomitant vaccination groups did not meet noninferiority requirements. However, a large retrospective cohort trial that compared the incidence of herpes zoster infections following concomitant versus nonconcomitant administration of PPV23 and zoster vaccine did not find a statistically significant between-group difference. CONCLUSIONS: Concomitant administration of zoster vaccine and PPV23 is advocated by the CDC and FDA to improve immunization rates among vaccine-eligible individuals. Since there is no direct evidence that simultaneous administration of zoster vaccine and PPV23 puts patients at increased risk of developing herpes zoster, the vaccines should be given during the same office visit to avoid a missed opportunity to vaccinate against 2 serious diseases.


Asunto(s)
Vacuna contra el Herpes Zóster/administración & dosificación , Herpes Zóster/epidemiología , Herpes Zóster/prevención & control , Vacunas Neumococicas/administración & dosificación , Animales , Centers for Disease Control and Prevention, U.S./tendencias , Quimioterapia Combinada , Herpes Zóster/diagnóstico , Humanos , Estados Unidos , United States Food and Drug Administration/tendencias
2.
Ann Pharmacother ; 45(12): 1571-5, 2011 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-22045905

RESUMEN

OBJECTIVE: To evaluate the efficacy and safety of ferumoxytol for use in magnetic resonance angiography (MRA) of the vasculature. DATA SOURCES: Literature was accessed through MEDLINE (1946-September 2011) and EMBASE (1947-September 2011) using the terms ferumoxytol, magnetic resonance imaging and angiography, blood pool agent, and superparamagnetic iron oxide. Reference citations from identified publications were reviewed for relevant information. STUDY SELECTION AND DATA EXTRACTION: All English-language articles and human studies (N = 9) were identified that evaluated ferumoxytol use in magnetic resonance imaging (MRI). Articles that evaluated the use of the drug in first-pass and equilibrium phase imaging of the vasculature were included (n = 4). DATA SYNTHESIS: Contrast agents for MRI improve disease characterization and diagnosis. Ferumoxytol, a medication approved for treatment of iron deficiency anemia in adults with chronic kidney disease, has superparamagnetic properties. As a blood pool agent, ferumoxytol remains primarily in the intravascular space. Therefore, its use in MRI may increase image sensitivity and specificity and have a decreased adverse effect profile compared to other contrast agents. Specifically, ferumoxytol may be an option for MRA, a specific type of MRI that images blood vessels. In the 4 studies evaluated here, ferumoxytol was administered primarily to healthy adults as an accumulative dose of 4 mg Fe/kg injected at 1 mL/sec. Not all studies reported adverse events and addressed safety monitoring. The evaluated studies are limited by small size, open-label design, and noncomparative methodology. CONCLUSIONS: Data from small pilot studies suggest that ferumoxytol may improve image quality in MRA; however, further investigation is necessary to establish its efficacy and safety. Large randomized, active-comparator trials are needed to establish optimal dosing, imaging procedures, and safety monitoring.


Asunto(s)
Medios de Contraste , Óxido Ferrosoférrico , Angiografía por Resonancia Magnética/métodos , Imagen por Resonancia Magnética/métodos , Humanos , Proyectos Piloto , Sensibilidad y Especificidad
3.
Ther Innov Regul Sci ; 53(4): 542-548, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30226799

RESUMEN

BACKGROUND: In September 2016, the Food and Drug Administration (FDA) published a draft guidance for industry, FDA's Application of Statutory Factors in Determining When a REMS Is Necessary, that detailed the factors the Agency considers in determining when a Risk Evaluation and Mitigation Strategy (REMS) is necessary. The objective of this study was to determine how the FDA has applied these criteria for newly approved drugs. METHODS: For the 3-year period, 2015-2017, which included a full year of FDA approvals both before and after the issuance of the draft guidance, publicly available FDA reviews were analyzed for all 113 approved products using the criteria outlined in the guidance. RESULTS: Of the 113 products approved, 5 required a REMS. The most cited reasons for not requiring a REMS for the remaining 108 drugs were that risks could be managed via professional labeling (87%), physicians (primarily specialists) were familiar with the management of the risks (76%), the risk profile was similar to other non-REMS marketed products (45%), products were used in a controlled setting (inpatient, infusion center) (30%), and/or safety concerns would be further evaluated by a postmarket study (14%). CONCLUSIONS: A review of Agency risk evaluations indicate that whether physicians are sufficiently familiar with and capable of managing a risk and that the health care setting where the product is administered is conducive to such management are leading factors in determining whether or not to require a REMS.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Aprobación de Drogas , Humanos , Riesgo , Estados Unidos , United States Food and Drug Administration
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