دورية أكاديمية
Potential safety signals for antibacterial agents from the Brazilian national pharmacovigilance database (Vigimed/VigiFlow).
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.) |
References: | Anesth Analg. 1964 Mar-Apr;43:137-9. (PMID: 14164930) Clin Pharmacol Ther. 1970 Jan-Feb;11(1):106-11. (PMID: 4312305) JAMA. 1966 Apr 11;196(2):181-3. (PMID: 4286165) Antimicrob Agents Chemother. 1996 Mar;40(3):825-6. (PMID: 8851625) Clin Neurol Neurosurg. 2012 Dec;114(10):1371-3. (PMID: 22551579) Front Microbiol. 2016 Jan 12;6:1543. (PMID: 26793178) Antibiotics (Basel). 2020 Aug 09;9(8):. (PMID: 32784880) JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. (PMID: 28604925) Pharmacoepidemiol Drug Saf. 2002 Jan-Feb;11(1):3-10. (PMID: 11998548) Pharmacoepidemiol Drug Saf. 2020 Apr;29(4):396-403. (PMID: 32092786) Br J Clin Pharmacol. 2021 Nov;87(11):4334-4340. (PMID: 33837554) Front Pharmacol. 2021 Dec 10;12:778386. (PMID: 34955847) Drug Saf. 2020 Aug;43(8):751-766. (PMID: 32602065) Br J Clin Pharmacol. 2011 Dec;72(6):905-8. (PMID: 21658092) BMC Public Health. 2015 Sep 17;15:908. (PMID: 26381376) Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):519-23. (PMID: 15317031) Stat Methods Med Res. 2013 Feb;22(1):39-56. (PMID: 21878461) Drug Saf. 2009;32(2):99-110. (PMID: 19236117) Ther Clin Risk Manag. 2016 Jun 09;12:927-9. (PMID: 27354808) Antibiotics (Basel). 2021 Dec 09;10(12):. (PMID: 34943724) Wien Klin Wochenschr. 2017 Feb;129(3-4):81-95. (PMID: 27770207) Bacteriol Rev. 1966 Jun;30(2):442-59. (PMID: 5327460) Ann Pharmacother. 2015 May;49(5):609. (PMID: 25870444) Psychopharmacology (Berl). 2016 Jul;233(13):2503-11. (PMID: 27113226) Clin Pharmacol Ther. 2012 Jun;91(6):1010-21. (PMID: 22549283) Br J Clin Pharmacol. 2021 Dec 22;:. (PMID: 34937122) SN Compr Clin Med. 2021;3(8):1691-1695. (PMID: 34095752) Front Pharmacol. 2020 Apr 15;11:428. (PMID: 32351386) Front Pharmacol. 2022 Feb 25;13:771953. (PMID: 35281929) Ther Innov Regul Sci. 2014 Jan;48(1):98-108. (PMID: 30231423) Br J Clin Pharmacol. 2009 Jun;67(6):599-604. (PMID: 19594526) Front Pharmacol. 2019 May 08;10:498. (PMID: 31139083) Drug Saf. 1997 Jun;16(6):355-65. (PMID: 9241490) Drug Saf. 2003;26(8):589-97. (PMID: 12825971) Front Pharmacol. 2022 Mar 21;13:844818. (PMID: 35387351) Pharmaceut Med. 2020 Oct;34(5):327-334. (PMID: 32930977) Front Pharmacol. 2020 Aug 06;11:964. (PMID: 32848722) |
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 |
كن أول من يترك تعليقا!