RESUMEN
BACKGROUND: The study aims to obtain the real-world safety profile of tetracyclines in children younger than 8 years old and provide reference for clinical drug applications. RESEARCH DESIGN AND METHODS: We made a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database through OpenVigil 2 and conducted a review of case reports regarding adverse drug reactions (ADRs) of tetracyclines in children younger than 8-year-old. RESULTS: FAERS analysis identified 32 ADRs of tetracyclines in children younger than 8-year-old. Respiratory, thoracic, and mediastinal disorders contained the most frequent ADRs among all system organ classes (SOCs). The top three positive signals with the highest proportional reporting ratio (PRR) were laryngeal injury, Horner's syndrome and methaemoglobinaemia. Sixteen published tetracyclines-associated cases in children younger than 8-year-old were identified in the literature, concentrating in three SOCs. Gastrointestinal disorders were the most commonly reported cases (n = 12). CONCLUSIONS: Several ADRs were newly reported only in children younger than 8-year-old in our research, including Horner's syndrome and methemoglobinemia. We recommended that the clinical practitioners should pay attention to the ADRs both in instruction and beyond the label. Take close care of children and timely intervene when the treatment is inevitable.
Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Antibacterianos , Bases de Datos Factuales , Tetraciclinas , United States Food and Drug Administration , Niño , Preescolar , Humanos , Lactante , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Factores de Edad , Antibacterianos/efectos adversos , Antibacterianos/administración & dosificación , Síndrome de Horner/inducido químicamente , Síndrome de Horner/epidemiología , Tetraciclinas/efectos adversos , Tetraciclinas/administración & dosificación , Estados UnidosRESUMEN
BACKGROUND: Most of the safety data of clobazam came from well-designed clinical trials, while the real-world information is insufficient. RESEARCH DESIGN AND METHODS: We performed a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database through OpenVigil 2 and conducted a systematic review of case reports regarding adverse drug reactions (ADR) linked to clobazam. RESULTS: The analysis of FAERS identified 595 ADR signals. Nervous system disorders cantains the most positive signals among all system organ classes (SOCs). Except for seizure (n = 1696) and somnolence (n = 813), drug interactions (n = 492) were the most frequently reported positive signals. A total of 502 unique citations were initially retrieved and 31 individual cases from 28 publications were included. Skin reactions were the most reactions (n = 9), containing three types of severe reactions not alerted in the instruction. Five cases were caused by interactions between clobazam and other antiepileptic drugs, etravirine-based antiretroviral therapy, omeprazole, or meropenem. One patient died of aspiration pneumonia. CONCLUSIONS: Clinicians must pay attention to severe skin reactions and monitor the signs of suspicious respiratory infections/inflammations and central sedation. Patients with skin reactions will benefit from the withdrawal of clobazam and the treatment with glucocorticoids. The drug reactions between clobazam with severe or moderate cytochrome P450 (CYP) 3A4 or CYP2C19 inhibitors or other antiepileptic drugs should also be alerted.
Asunto(s)
Anticonvulsivantes , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Clobazam/efectos adversos , Anticonvulsivantes/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Interacciones FarmacológicasRESUMEN
BACKGROUND: The study aims to obtain the safety profile of riluzole in the real world and provide reference for clinical drug applications. RESEARCH DESIGN AND METHODS: Proportional reporting ratio (PRR) was used to detect riluzole adverse drug reactions (ADRs) from the data between the first quarter of 2004 and the third quarter of 2022 in the FDA adverse event reporting system database (FAERS). Case reports of riluzole published in PubMed, Embase, and Web of Science before November 2022 were reviewed, and patient's data were extracted. RESULTS: FAERS analysis identified 86 ADRs. Gastrointestinal system disorders and respiratory, thoracic, and mediastinal disorders account for 12 of the top 20 most frequent ADRs. Similarly, 9 of the 20 highest PRR ADRs were gastrointestinal system disorders and respiratory, thoracic, and mediastinal disorders. Twenty-two published riluzole-associated cases were identified in the literature. Respiratory, thoracic, and mediastinal disorders were the most commonly reported cases (n = 9), followed by gastrointestinal disorders, pancreatitis (n = 5). CONCLUSIONS: Strong ADRs between riluzole and pancreatitis were identified, which reminds clinicians to monitor patients carefully. For patients with respiratory symptoms, clinicians should pay attention to distinguish the cause of their occurrence, and take appropriate measures. Beware that riluzole may increase the risk of inflammatory reactions and inappropriate vasopressin secretion and hyponatremia due to respiratory failure.
Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Enfermedades Gastrointestinales , Pancreatitis , Humanos , Riluzol/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos , Bases de Datos Factuales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Enfermedades Gastrointestinales/inducido químicamente , Enfermedades Gastrointestinales/epidemiologíaRESUMEN
Coronavirus Disease 2019 (COVID-19) has sparked a global pandemic, affecting more than 4 million people worldwide. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause acute lung injury (ALI) and even acute respiratory distress syndrome (ARDS); with a fatality of 7.0 %. Accumulating evidence suggested that the progression of COVID-19 is associated with lymphopenia and excessive inflammation, and a subset of severe cases might exhibit cytokine storm triggered by secondary hemophagocytic lymphohistiocytosis (sHLH). Furthermore, secondary bacterial infection may contribute to the exacerbation of COVID-19. We recommend using both IL-10 and IL-6 as the indicators of cytokine storm, and monitoring the elevation of procalcitonin (PCT) as an alert for initiating antibacterial agents. Understanding the dynamic progression of SARS-CoV-2 infection is crucial to determine an effective treatment strategy to reduce the rising mortality of this global pandemic.