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2.
Nurs Clin North Am ; 56(1): 1-21, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33549278

RESUMEN

The Food and Drug Administration (FDA) classifies herbal preparations as food supplements. New herbal supplements and products are not governed by the strict FDA drug approval process and there is no premarket approval required. The FDA prohibits manufacturers and distributors from marketing adulterated or misbranded products but does not rigorously define safe practices. Scientific evidence related to herbal supplements is limited. Herbal supplements have been associated with adverse reactions and herbal-drug interactions. Information and precautions for 20 common herbal supplements, including St. John's wort, ginseng, echinacea, and ginkgo, are reviewed. Resources for consumers and health care professionals are highlighted.


Asunto(s)
Suplementos Dietéticos/efectos adversos , Suplementos Dietéticos/estadística & datos numéricos , Fitoterapia/efectos adversos , Fitoterapia/estadística & datos numéricos , Preparaciones de Plantas/efectos adversos , Preparaciones de Plantas/uso terapéutico , Ginkgo biloba/efectos adversos , Humanos , Hypericum/efectos adversos , Kava/efectos adversos , Panax/efectos adversos , Acúfeno/terapia , Estados Unidos , United States Food and Drug Administration
3.
BMJ Open ; 11(2): e042965, 2021 02 08.
Artículo en Inglés | MEDLINE | ID: mdl-33558355

RESUMEN

OBJECTIVE: To describe the pattern of hydroxychloroquine use and examine the association between hydroxychloroquine use and clinical outcomes arising from changes in the US Food and Drug Administration (FDA)'s recommendation during the coronavirus disease 2019 (COVID-19) pandemic. DESIGN: A retrospective cross-sectional analysis. SETTING AND PARTICIPANTS: We included hospitalised adult patients at Northwell Health hospitals with confirmed COVID-19 infections between 1 March 2020 and 11 May 2020. We categorised changes in the FDA's recommendation as pre-FDA approval (1 March 2020-27 March 2020), FDA approval (28 March 2020-23 April 2020), and FDA warning (24 April 2020-11 May 2020). The hydroxychloroquine-treated group received at least one dose within 48 hours of hospital admission. PRIMARY OUTCOME: A composite of intubation and inpatient death. RESULTS: The percentages of patients who were treated with hydroxychloroquine were 192/2202 (8.7%) pre-FDA approval, 2902/6741 (43.0%) FDA approval, and 176/1066 (16.5%) FDA warning period (p<0.001). Using propensity score matching, there was a higher rate of the composite outcome among patients treated with hydroxychloroquine (49/192, 25.5%) compared with no hydroxychloroquine (66/384, 17.2%) in the pre-FDA approval period (p=0.03) but not in the FDA approval period (25.5% vs 22.6%, p=0.08) or the FDA warning (21.0% vs 15.1%, p=0.11) periods. Coincidently, there was an increase in number of patients with COVID-19 and disease severity during the FDA approval period (24.1% during FDA approval vs 21.4% during pre-FDA approval period had the composite outcome). Hydroxychloroquine use was associated with increased odds of the composite outcome during the pre-FDA approval period (OR=1.65 (95% CI 1.09 to 2.51)) but not during the FDA approval (OR=1.17 (95% CI 0.99 to 1.39)) and FDA warning (OR=1.50 (95% CI 0.94 to 2.39)) periods. CONCLUSIONS: Hydroxychloroquine use was associated with adverse clinical outcomes only during the pre-FDA approval period but not during the FDA approval and warning periods, even after adjusting for concurrent changes in the percentage of patients with COVID-19 treated with hydroxychloroquine and the number (and disease severity) of hospitalised patients with COVID-19 infections.


Asunto(s)
/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , United States Food and Drug Administration , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Hidroxicloroquina/efectos adversos , Masculino , Medicare , Persona de Mediana Edad , New York , Puntaje de Propensión , Estudios Retrospectivos , Estados Unidos , Adulto Joven
4.
Int J Biol Macromol ; 172: 524-541, 2021 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-33454328

RESUMEN

The infectious microscopic viruses invade living cells to reproduce themselves, and causes chronic infections such as HIV/AIDS, hepatitis B and C, flu, etc. in humans which may lead to death if not treated. Different strategies have been utilized to develop new and superior antiviral drugs to counter the viral infections. The FDA approval of HIV nucleoside reverse transcriptase inhibitor, zidovudine in 1987 boosted the development of antiviral agents against different viruses. Currently, there are a number of combination drugs developed against various viral infections to arrest the activity of same or different viral macromolecules at multiple stages of its life cycle; among which majority are targeted to interfere with the replication of viral genome. Besides these, other type of antiviral molecules includes entry inhibitors, integrase inhibitors, protease inhibitors, interferons, immunomodulators, etc. The antiviral drugs can be toxic to human cells, particularly in case of administration of combination drugs, and on the other hand viruses can grow resistant to the antiviral drugs. Furthermore, emergence of new viruses like Ebola, coronaviruses (SARS-CoV, SARS-CoV-2) emphasizes the need for more innovative strategies to develop better antiviral drugs to fight the existing and the emerging viral infections. Hence, we reviewed the strategic enhancements in developing antiviral drugs for the treatment of different viral infections over the years.


Asunto(s)
Antivirales/uso terapéutico , Aprobación de Drogas , United States Food and Drug Administration , Virosis/tratamiento farmacológico , Humanos , Pandemias , Estados Unidos , Virosis/epidemiología
6.
MMWR Recomm Rep ; 70(1): 1-12, 2021 01 08.
Artículo en Inglés | MEDLINE | ID: mdl-33417593

RESUMEN

This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) in the United States. The vaccine contains rice-derived recombinant human serum albumin and live attenuated recombinant vesicular stomatitis virus (VSV) in which the gene encoding the glycoprotein of VSV was replaced with the gene encoding the glycoprotein of Ebola virus species Zaire ebolavirus. Persons with a history of severe allergic reaction (e.g., anaphylaxis) to rice protein should not receive Ervebo. This is the first and only vaccine currently licensed by the Food and Drug Administration for the prevention of Ebola virus disease (EVD). These guidelines will be updated based on availability of new data or as new vaccines are licensed to protect against EVD.ACIP recommends preexposure vaccination with Ervebo for adults aged ≥18 years in the U.S. population who are at highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus because they are responding to an outbreak of EVD, work as health care personnel at federally designated Ebola treatment centers in the United States, or work as laboratorians or other staff at biosafety level 4 facilities in the United States. Recommendations for use of Ervebo in additional populations at risk for exposure and other settings will be considered and discussed by ACIP in the future.


Asunto(s)
Vacunas contra el Virus del Ébola/administración & dosificación , Fiebre Hemorrágica Ebola/prevención & control , Adulto , Comités Consultivos , Fiebre Hemorrágica Ebola/epidemiología , Humanos , Estados Unidos/epidemiología , United States Food and Drug Administration
7.
Molecules ; 26(3)2021 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-33504104

RESUMEN

Although the pharmaceutical industry will remember 2020 as the year of COVID-19, it is important to highlight that this year has been the second-best-together with 1996-in terms of the number of drugs accepted by the US Food and Drug Administration (FDA). Each of these two years witnessed the authorization of 53 drugs-a number surpassed only in 2018 with 59 pharmaceutical agents. The 53 approvals in 2020 are divided between 40 new chemical entities and 13 biologic drugs (biologics). Of note, ten monoclonal antibodies, two antibody-drug conjugates, three peptides, and two oligonucleotides have been approved in 2020. Close inspection of the so-called small molecules reveals the significant presence of fluorine atoms and/or nitrogen aromatic heterocycles. This report analyzes the 53 new drugs of the 2020 harvest from a strictly chemical perspective, as it did for those authorized in the previous four years. On the basis of chemical structure alone, the drugs that received approval in 2020 are classified as the following: biologics (antibodies, antibody-drug conjugates, and proteins); TIDES (peptide and oligonucleotides); natural products; fluorine-containing molecules; nitrogen aromatic heterocycles; and other small molecules.


Asunto(s)
Aprobación de Drogas/legislación & jurisprudencia , Industria Farmacéutica , United States Food and Drug Administration/legislación & jurisprudencia , Historia del Siglo XXI , Estados Unidos
9.
Eur Rev Med Pharmacol Sci ; 25(1): 503-517, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33506942

RESUMEN

OBJECTIVE: To evaluate the diagnostic accuracy of the Food and Drug Administration Emergency Use Authorization (FDA-EUA) authorized point-of-care tests (POCTs) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MATERIALS AND METHODS: A systematic literature search was conducted using the PubMed, Embase, and Web of Science databases for articles published till August 10, 2020. We included studies providing information regarding diagnostic test accuracy of FDA-EUA POCTs for SARS-CoV-2 detection. The methodologic quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The review protocol is registered in the International Prospective Register of Systematic Reviews (protocol number CRD42020202248). RESULTS: We included 26 studies describing a total of 3242 samples. The summary sensitivity and specificity were 0.94 [95% confidence interval (CI): 0.88-0.97] and 1.00 (95% CI: 0.99-1.00), respectively. The area under the summary receiver operating characteristic curve was 1.00 (95% CI: 0.99-1.00). A pooled analysis based on the index test revealed a summary sensitivity and specificity of Cepheid Xpert Xpress SARS-CoV-2 [0.99 (95% CI: 0.97-1.00) and 0.99 (95% CI: 0.94-1.00, respectively)] and ID NOW COVID-19 [0.78 (95% CI: 0.74-0.82) and 1.00 (95% CI: 0.98-1.00), respectively]. CONCLUSIONS: FDA-EUA POCTs, especially molecular assays, have high sensitivity, specificity, and overall diagnostic accuracy for detecting SARS-CoV-2. If approved, FDA-EUA POCTs can provide a rapid and practical way to identify infected individuals early on and help to limit the strain on the healthcare system. However, more high-quality clinical data are required to support our results.


Asunto(s)
/métodos , /diagnóstico , Pruebas en el Punto de Atención/normas , /aislamiento & purificación , Técnicas de Laboratorio Clínico/métodos , Técnicas de Laboratorio Clínico/normas , Humanos , Garantía de la Calidad de Atención de Salud , Sensibilidad y Especificidad , Estados Unidos , United States Food and Drug Administration
12.
Int J Nanomedicine ; 16: 161-184, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33447033

RESUMEN

The emergence of nanotechnology as a key enabling technology over the past years has opened avenues for new and innovative applications in nanomedicine. From the business aspect, the nanomedicine market was estimated to worth USD 293.1 billion by 2022 with a perception of market growth to USD 350.8 billion in 2025. Despite these opportunities, the underlying challenges for the future of engineered nanomaterials (ENMs) in nanomedicine research became a significant obstacle in bringing ENMs into clinical stages. These challenges include the capability to design bias-free methods in evaluating ENMs' toxicity due to the lack of suitable detection and inconsistent characterization techniques. Therefore, in this literature review, the state-of-the-art of engineered nanomaterials in nanomedicine, their toxicology issues, the working framework in developing a toxicology benchmark and technical characterization techniques in determining the toxicity of ENMs from the reported literature are explored.


Asunto(s)
Nanomedicina , Nanoestructuras/química , Nanotecnología/métodos , Aprobación de Drogas , Salud , Humanos , Nanoestructuras/toxicidad , Estados Unidos , United States Food and Drug Administration
14.
Am J Nurs ; 121(1): 22-24, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-33350691

RESUMEN

Remdesivir (Veklury) is the first antiviral drug approved to treat patients ages 12 and older who are hospitalized with COVID-19.The drug is administered via slow IV infusion.Elevated liver enzymes are common with treatment. Hypersensitivity reactions, including anaphylaxis, are possible.


Asunto(s)
Adenosina Monofosfato/análogos & derivados , Alanina/análogos & derivados , Antivirales/uso terapéutico , /tratamiento farmacológico , Adenosina Monofosfato/uso terapéutico , Alanina/uso terapéutico , Ensayos Clínicos como Asunto , Aprobación de Drogas , Humanos , Estados Unidos , United States Food and Drug Administration
15.
MMWR Morb Mortal Wkly Rep ; 69(5152): 1653-1656, 2021 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-33382675

RESUMEN

On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 µg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.


Asunto(s)
/administración & dosificación , Inmunización/normas , Guías de Práctica Clínica como Asunto , Adolescente , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Comités Consultivos , Anciano , Anciano de 80 o más Años , /efectos adversos , Centers for Disease Control and Prevention, U.S. , Ensayos Clínicos Fase III como Asunto , Aprobación de Drogas , Urgencias Médicas , Humanos , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Estados Unidos/epidemiología , United States Food and Drug Administration , Adulto Joven
16.
Ann Emerg Med ; 77(1): 91-102, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33353592

RESUMEN

As currently written, national regulatory guidance on procedural sedation has elements that are contradictory, confusing, and out of date. As a result, hospital procedural sedation policies are often widely inconsistent between institutions despite similar settings and resources, putting emergency department (ED) patients at risk by denying them uniform access to safe, effective, and appropriate procedural sedation care. Many hospitals have chosen to take overly conservative stances with respect to regulatory compliance to minimize their perceived risk. Herein, we review and critique standards and policies from the Centers for Medicare & Medicaid Services, The Joint Commission, state nursing boards, the Food and Drug Administration, and others with respect to their effect on ED procedural sedation. Where appropriate, we recommend modifications of and enhancements to their guidance that would improve the access of ED patients to modern, safe, and effective procedural sedation care.


Asunto(s)
Sedación Consciente , Servicio de Urgencia en Hospital , Regulación Gubernamental , Centers for Medicare and Medicaid Services, U.S./normas , Sedación Consciente/métodos , Servicio de Urgencia en Hospital/legislación & jurisprudencia , Humanos , Estados Unidos , United States Food and Drug Administration/normas
17.
Radiol Clin North Am ; 59(1): 41-55, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33222999

RESUMEN

Screening mammography aims to identify small, node-negative breast cancers when they are still curable while maintaining an acceptable range of false-positive recalls and biopsies. The mammography audit is a powerful tool to help radiologists understand their performance with respect to that goal. This article defines audit terms and describes how to use collected and derived data to perform a mammography audit. Accepted benchmarks are discussed as well as their applicability to radiologists and breast imaging practices in the United States. Special considerations regarding volumes and radiologist characteristics are explored, because these factors may affect audit results.


Asunto(s)
Neoplasias de la Mama/diagnóstico por imagen , Mamografía/normas , Auditoría Médica/métodos , Control de Calidad , Detección Precoz del Cáncer/normas , Femenino , Humanos , Tamizaje Masivo/normas , Estados Unidos , United States Food and Drug Administration
18.
Ann Pharmacother ; 55(1): 89-97, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-32578447

RESUMEN

OBJECTIVE: To review the efficacy and safety of the high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) in the prevention of influenza in older adults. DATA SOURCES: A literature search was performed using PubMed and Google Scholar with the search terms high-dose, influenza vaccine, and quadrivalent. Other resources included the Centers for Disease Control and Prevention (CDC), the prescribing information, and the manufacturer's website. STUDY SELECTION AND DATA EXTRACTION: All relevant English-language articles of studies assessing the efficacy and safety of HD-IIV4 were included. DATA SYNTHESIS: HD-IIV4 is licensed by the Food and Drug Administration for the prevention of influenza in adults aged 65 years and older. The safety and immunogenicity of HD-IIV4 was demonstrated in a phase 3 trial, and the efficacy of the trivalent formulation (HD-IIV3) was demonstrated in a phase 3b-4 trial. HD-IIV4 carries a warning regarding the occurrence of Guillain-Barré syndrome. Adverse reactions, including injection-site pain and myalgia, were reported more frequently with HD-IIV4 than with HD-IIV3. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Although the CDC recommends any age-appropriate influenza vaccine for adults aged 65 years and older, HD-IIV4 was associated with improved immunogenicity against the added B strain and HD-IIV3 provided better protection against influenza than the standard-dose vaccine. Other influenza vaccines have weaker evidence of efficacy in older adults. Therefore, HDIIV4 should be recommended as the vaccine of choice in adults aged 65 years and older. CONCLUSION: HD-IIV4 has proven immunogenic, safe, and effective in preventing influenza in older adults and should be recommended as the vaccine of choice in this patient population.


Asunto(s)
Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Anciano , Anciano de 80 o más Años , Anticuerpos Antivirales/inmunología , Ensayos Clínicos como Asunto , Femenino , Pruebas de Inhibición de Hemaglutinación , Humanos , Inmunogenicidad Vacunal/efectos de los fármacos , Vacunas contra la Influenza/efectos adversos , Vacunas contra la Influenza/inmunología , Gripe Humana/inmunología , Masculino , Dolor/inducido químicamente , Estados Unidos , United States Food and Drug Administration , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/efectos adversos , Vacunas de Productos Inactivados/inmunología
19.
Ann Pharmacother ; 55(1): 98-104, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-32590907

RESUMEN

OBJECTIVE: To provide a concise review of the new Food and Drug Administration (FDA)-approved antipsychotic, lumateperone, for use in schizophrenia. DATA SOURCES: A literature search of PubMed was performed (January 2000 to May 2020) using the following key terms: lumateperone, Caplyta, and ITI-007. Abstracts from conferences, review articles, clinical trials, and drug monographs were reviewed. STUDY SELECTION AND DATA EXTRACTION: Relevant English-language monographs and studies conducted in humans were considered. DATA SYNTHESIS: Lumateperone was FDA approved for the treatment of schizophrenia in December 2019 based on 2 published randomized, double-blind, placebo-controlled trials. Lumateperone's pharmacology is consistent with that of other second-generation antipsychotics in that it has a higher affinity for the serotonin (5-HT2A) receptors compared with dopamine (D2) receptors but with lower affinities for α-1 and histaminergic receptors. In addition, it serves as a presynaptic dopamine partial agonist, serotonin reuptake inhibitor, and an indirect modulator of glutamatergic systems. Based on the 4-week clinical trials, lumateperone was well tolerated. Most common treatment-emergent adverse events were headache, somnolence, and dizziness. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: At this time, lumateperone had a statistically significant reduction in Positive and Negative Syndrome Scale when compared with placebo and was not significantly associated with the extrapyramidal symptoms (EPS) and metabolic adverse effects commonly seen with other antipsychotics. CONCLUSIONS: Lumateperone has the potential to benefit individuals with schizophrenia who are intolerant to the EPSs or metabolic adverse effects of other antipsychotics. However, further head-to-head trials with commercially available antipsychotics are still required to assist in establishing its role in treatment.


Asunto(s)
Antipsicóticos/uso terapéutico , Compuestos Heterocíclicos de 4 o más Anillos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Antipsicóticos/administración & dosificación , Antipsicóticos/efectos adversos , Antipsicóticos/farmacocinética , Compuestos Heterocíclicos de 4 o más Anillos/administración & dosificación , Compuestos Heterocíclicos de 4 o más Anillos/efectos adversos , Compuestos Heterocíclicos de 4 o más Anillos/farmacocinética , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Estados Unidos , United States Food and Drug Administration
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