دورية أكاديمية
أعرض في EDS

Potential safety signals for antibacterial agents from the Brazilian national pharmacovigilance database (Vigimed/VigiFlow).

التفاصيل البيبلوغرافية
العنوان: Potential safety signals for antibacterial agents from the Brazilian national pharmacovigilance database (Vigimed/VigiFlow).
المؤلفون: Barbosa LHLA; Institute of Biosciences, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil., Silva ARO; Observatório de Vigilância e Uso de Medicamentos, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Carvalho-Assef APD; Laboratório de Pesquisa em Infecção Hospitalar, Instituto Oswaldo Cruz, Fiocruz, Rio de Janeiro, Brazil., Lima EC; Observatório de Vigilância e Uso de Medicamentos, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., da Silva FAB; Scientific Computing Program, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
المصدر: Frontiers in pharmacology [Front Pharmacol] 2022 Sep 20; Vol. 13, pp. 948339. Date of Electronic Publication: 2022 Sep 20 (Print Publication: 2022).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Frontiers Media] Country of Publication: Switzerland NLM ID: 101548923 Publication Model: eCollection Cited Medium: Print ISSN: 1663-9812 (Print) Linking ISSN: 16639812 NLM ISO Abbreviation: Front Pharmacol Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: [Lausanne : Frontiers Media]
مستخلص: Antibacterial drugs are a widely used drug class due to the frequency of infectious diseases globally. Risks knowledge should ground these medicines' selection. Data mining in large databases is essential to identify early safety signals and to support pharmacovigilance systems. We conducted a cross-sectional study to assess adverse drug events related to antibiotics reporting between December 2018 and December 2021 in the Brazilian database (Vigimed/VigiFlow). We used the Reporting Odds Ratio (ROR) disproportionality analysis method to identify disproportionate reporting signals (SDR), referring to statistical combinations between drugs and adverse events. Vancomycin was the most reported antibiotic ( n = 1,733), followed by ceftriaxone ( n = 1,277) and piperacillin and tazobactam ( n = 1,024). We detected 294 safety signals related to antibacterials. We identified azithromycin leading in the number of safety signals ( n = 49), followed by polymyxin B ( n = 25). Of these, 95 were not provided for in the drug label and had little or no reports in the medical literature. Three serious events are associated with ceftazidime and avibactam, a new drug in the Brazilian market. We also found suicide attempts as a sign associated with amoxicillin/clavulanate. Gait disturbance, a worrying event, especially in the elderly, was associated with azithromycin. Our findings may help guide further pharmacoepidemiologic studies and monitoring safety signals in pharmacovigilance.
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2022 Barbosa, Silva, Carvalho-Assef, Lima and da Silva.)
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فهرسة مساهمة: Keywords: adverse drug reaction reporting systems; anti-bacterial agents; drug-related side effects and adverse reactions; pharmacovigilance; safety signals; spontaneous reports
تواريخ الأحداث: Date Created: 20221007 Latest Revision: 20221009
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC9530932
DOI: 10.3389/fphar.2022.948339
PMID: 36204235
قاعدة البيانات: MEDLINE
الوصف
تدمد:1663-9812
DOI:10.3389/fphar.2022.948339