Analysis of Adverse Reactions in Elderly Patients Based on Quantitative Methods of Signal Detection

Затолочина, К. Э.; Ушкалова, Е. А.; Казаков, А. С.; Зырянов, С. К.; Поливанов, В. А.

doi:10.30895/2312-7821-2021-9-3-144-153

Bezopasnost' i risk farmakoterapii

2021

DOI: 10.30895/2312-7821-2021-9-3-144-153

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Analysis of Adverse Reactions in Elderly Patients Based on Quantitative Methods of Signal Detection

К. Э. Затолочина

Е. А. Ушкалова

А. С. Казаков

et al.

Abstract: Резюме. Увеличение рисков развития нежелательных реакций у пациентов пожилого и старческого возраста по сравнению с более молодыми -известная проблема фармакотерапии. Российская база данных фармаконадзора содержит значительное количество индивидуальных спонтанных сообщений о нежелательной реакции, касающихся пациентов 65 лет и старше. Рост репортирования о нежелательных реакциях делает затруднительным выявление сигналов о безопасности лекарственных средств исключительно на основе качественных подходов, что вед… Show more

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Cited by 3 publications

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Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring

Сокова¹,

Arkhipov²,

Казаков³

et al. 2022

Bezopasnost' i risk farmakoterapii

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Aztreonam is the only approved monocyclic β-lactam antibiotic for human use that is active against Gram-negative aerobes, primarily Pseudomonas аeruginosa. Aztreonam has been used for more than 35 years, and aztreonam lysine has been on the market for 15 years. Although the medicinal products show clinical and microbiological efficacy in severe infections and are significant for cystic fibrosis patients, little information is published on their safety. In the meantime, new data have accumulated.The aim of the study was to analyse the data on adverse reactions in patients of different age groups receiving aztreonam, collected in the safety monitoring databases VigiBase and Pharmacovigilance.Materials and methods: the data on adverse reactions associated with aztreonam, in any dosage form, from the individual case reports submitted to VigiBase (the database of the Uppsala Monitoring Centre) before 15.09.2021 and to Pharmacovigilance (the database for spontaneous reports in the Automated Information System of the Federal Service for Surveillance in Healthcare of the Russian Federation) before 05.10.2021.Results: the analysis of adverse reactions during the use of aztreonam for approved indications showed differences in frequency, types and severity of the adverse reactions amongst the age groups. The most common adverse reaction with aztreonam was cystic fibrosis referred to in 1828 reports (12.0%). It was recorded more often in patients aged 18–44 years (39.2%).Conclusions: the data obtained allowed the authors to identify a new safety signal for aztreonam, namely an increased risk of inefficacy or insufficient efficacy in cystic fibrosis considered an adverse reaction in the individual reports from the databases of spontaneous reports. Confirmation of the signal requires further monitoring.

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Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring

Сокова¹,

Arkhipov²,

Казаков³

et al. 2022

Bezopasnost' i risk farmakoterapii

Self Cite

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Safety of COVID-19 vaccines

Романов

2022

Bezopasnost' i risk farmakoterapii

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By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year’s worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines.The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022.Materials and methods: the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword “Covid-19 vaccine” in combination with the trade names of all 38 coronavirus vaccines.Results: the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients.Conclusions: the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.

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Report of the Russian database on adverse drug reactions for COVID-19-related drugs with a focus on favipiravir

Mishinova,

Syraeva,

Kolbin

et al. 2023

CMAC

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Objective. The purpose of this study is to systematize and comprehensively evaluate safety data on the drug favipiravir using the national pharmacovigilance database of the Russian Federation. Materials and Methods. The report is based on spontaneous reports in the national automated information system of pharmacovigilance of the Russian Federation for the reporting period from 01.01.2020 – 04.07.2022. To identify safety signals we used disproportionality analysis, to estimate consumption of favipiravir – indicator of the number of consumed DDDs, we additionally performed review of concomitant therapy as a risk factor for serious adverse reactions. Results. A total of 412 reports of 585 adverse reactions was included in the analytic phase. The largest number of reports referred to liver and biliary tract disorders – 166 (38%), gastrointestinal disorders – 93 (16%), changes in laboratory and instrumental data – 53 (9%), and immune system disorders – 44 (7%). A total consumption of oral favipiravir expressed in the number of maintenance daily doses for 2021 was 46,417,274.87, i.e. 30 times the consumption of remdesivir and 6 times the consumption of hydroxychloroquine. One potential statistical safety signal such as hypercreatininemia was identified. Conclusions. Development of hypercreatininemia is a potential statistical safety signal of favipiravir, which requires further validation.

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Analysis of Adverse Reactions in Elderly Patients Based on Quantitative Methods of Signal Detection

Cited by 3 publications

References 21 publications

Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring

Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring

Safety of COVID-19 vaccines

Report of the Russian database on adverse drug reactions for COVID-19-related drugs with a focus on favipiravir

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