Toxic reactions of non-steroidal anti-inflammatory drugs in the Russian Federation, analysis of the national database “Pharmacovigilance”
https://doi.org/10.37489/2588-0519-2022-4-73-82
Abstract
Non-steroidal anti-inflammatory drugs are widely used by patients and medical workers, both in the Russian Federation and abroad. Despite the well-established public opinion about the safety of this group of drugs, their use is associated with toxic reactions. This study analyzed the download of the national database “Pharmacovigilance” for 11 years (for the period 2010 to 2020) with the identification of the main representatives of this class of drugs that cause adverse reactions. To compare several independent samples of patients who received different groups of NSAIDs, Kruskel-Wallis ANOVA rank analysis of variations was used using Microsoft Excel 2013, STATISTICA 10.0 packages. Based on the results obtained, it can be concluded that the main proportion of adverse drug reactions (ADR) is associated with the female sex and the use of metamizole sodium. In addition, fatal AEs have been reported, most of which are associated with the use of paracetamol.
About the Authors
G. I. SyraevaRussian Federation
Syraeva Gulnara I., Deputy Quality Manager, Limited Liability Company “Research center Eco-safety”; fulltime postgraduate student of the Department of Clinical Pharmacology and Evidence-based Medicine FSBEI HE I. P. Pavlov SPbSMU MOH Russia
Saint Petersburg
V. B. Vasilyuk
Russian Federation
Vasilyuk Vasiliy B., Dr. Sci. (Med.), professor of the Department of Toxicology, Extreme and Diving Medicine North-Western State Medical University named after I. I. Mechnikov; Managing the Limited Liability Company “Research center Eco-safety”
Saint Petersburg
A. V. Verveda
Russian Federation
Verveda Aleksey B., Cand. Sci. (Med.), Leading Researcher, Laboratory of Drug Toxicology, Golikov Research Center of Toxicology; Senior Researcher of Scientific Work the Limited Liability Company “Research center Eco-safety”
Saint Petersburg
M. V. Faraponova
Russian Federation
Faraponova Maria V., deputy Manager for Scientific Work
Saint Petersburg
A. S. Kolbin
Russian Federation
Kolbin Alexey S., Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I. P. Pavlov SPbSMU MOH Russia
Saint Petersburg
V. G. Borovskaya
Russian Federation
Borovskaya Valentina G., Monitor CRO the Limited Liability Company “Research center Eco-safety”; medical resident of Department of clinical pharmacology and evidence-based medicine, FSBEI HE I. P. Pavlov SPbSMU MOH Russia
Saint Petersburg
References
1. Bunchorntavakul C, Reddy KR. Acetaminophen-related hepatotoxicity. Clin Liver Dis. 2013;17(4):587–607, viii. doi:10.1016/j.cld.2013.07.005
2. McGill MR, Jaeschke H. Metabolism and disposition of acetaminophen: recent advances in relation to hepatotoxicity and diagnosis. Pharm Res. 2013;30(9):2174–87. doi:10.1007/s11095-013-1007-6
3. Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011;89(6):806–15. doi:10.1038/clpt.2011.58
4. Davidson DG, Eastham WN. Acute liver necrosis following overdose of paracetamol. Br Med J. 1966;2(5512):497–9. doi:10.1136/bmj.2.5512.497
5. Syraeva GI, Kolbin AS. Nonsteroidal anti-inflammatory drugs’ adverse drug reactions: 10 years of national database data. Kachestvennaya klinicheskaya praktika = Good Clinical Practice. 2021;(4):16–26. (In Russ). doi:10.37489/2588-0519-2021-4-16-26
6. European Association for the Study of the Liver. EASL clinical guidelines: drug-induced liver injury. J Hepatol. 2019;70(6):1222–61. doi:10.1016/j.jhep.2019.02.014
7. Vasilyuk VB, Faraponova MV, Syraeva GI. Selection of NSAIDs for the treatment of acute and chronic pain in patients with rheumatoid arthritis at the outpatient stage. RMJ. 2020;12:30–4. (In Russ).
8. Официальный сайт Росздравнадзора. 2020 г. [интернет]. Доступ по ссылке: http://www.roszdravnadzor.ru/services/npr_ais (доступ от 30.09.2022).
9. Federal`ny`j zakon Rossijskoj Federacii ot 12.04.2010 g. № 61-FZ (red. ot 14.07.2022 g.) “Ob obrashchenii lekarstvenny`x sredstv”, stat`ya 64 “Farmakonadzor”. (In Russ). https://fzrf.su/zakon/ob-obrashchenii-lekarstvennyh-sredstv-61-fz/st-64.php.
10. Syraeva GI, Kolbin AS, Matveev AV, Panezhina VS. Comparative review of methodologies for estimating the cost of adverse drug reactions in the Russian Federation and Brazil. Pharmacy & Pharmacology. 2020;8(5):336–44. (In Russ). doi:10.19163/2307-9266-2020-8-5-336-344
11. Reshenie Soveta EEK ob utverzhdenii Pravil nadlezhashchej praktiki farmakonadzora Evrazijskogo ekonomicheskogo soyuza ot 03.11.2016 g., vstupivshih v silu 06.05.2017. (In Russ). https://docs.cntd.ru/document/456026106.
12. European Medicines Agency: Guideline on good pharmacovigilance practices (GVP) Module VI–Management and reporting of adverse reactions to medicinal products (Rev 1).201. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/09/WC500172402.pdf.
Review
For citations:
Syraeva G.I., Vasilyuk V.B., Verveda A.V., Faraponova M.V., Kolbin A.S., Borovskaya V.G. Toxic reactions of non-steroidal anti-inflammatory drugs in the Russian Federation, analysis of the national database “Pharmacovigilance”. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2022;(4):73-82. (In Russ.) https://doi.org/10.37489/2588-0519-2022-4-73-82