Safety Profile of Meloxicam: Analysis of Adverse Event Reports in the Czech Republic

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F25%3AN0000016" target="_blank" >RIV/00023698:_____/25:N0000016 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/25:10503883 RIV/00064165:_____/25:10503883

Výsledek na webu

<a href="https://www.nel.edu/safety-profile-of-meloxicam-analysis-of-adverse-event-reports-in-the-czech-republic-3017/" target="_blank" >https://www.nel.edu/safety-profile-of-meloxicam-analysis-of-adverse-event-reports-in-the-czech-republic-3017/</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Safety Profile of Meloxicam: Analysis of Adverse Event Reports in the Czech Republic

Popis výsledku v původním jazyce

INTRODUCTION: Meloxicam is a preferential cyclooxygenase-2 inhibitor widely prescribed for rheumatic diseases. Given its long clinical use, further assessment of its safety profile remains relevant. AIM OF STUDY: This study aimed to evaluate the safety profile of meloxicam in the Czech Republic using national pharmacovigilance data, and to compare reported adverse events (AEs) with findings from the WHO VigiAccess database. METHODS: We analyzed all meloxicam-related AEs reported to the State Institute for Drug Control (SUKL) between January 2015 and December 2020, as well as related data extracted from the World Health Organization's pharmacovigilance VigiAccess database. AEs were classified according to MedDRA terminology. National drug utilization data were obtained from SUKL to provide an estimate of meloxicam exposure, expressed in defined daily doses (DDD). RESULTS: Over six years, 24 AE reports were identified in the Czech Republic (population 10.7 million). During the same period, meloxicam consumption reached 71,512,140 DDD, corresponding to 4.64 DDD/1000 inhabitants/day. The most frequently reported AEs were hypersensitivity reactions (10 cases), followed by gastrointestinal events (4 cases), nervous system disorders (4 cases), and isolated cardiovascular toxicity (1 case of heart failure). CONCLUSION: In the context of national exposure, only a limited number of meloxicam-related AEs were reported.

Název v anglickém jazyce

Safety Profile of Meloxicam: Analysis of Adverse Event Reports in the Czech Republic

Popis výsledku anglicky

INTRODUCTION: Meloxicam is a preferential cyclooxygenase-2 inhibitor widely prescribed for rheumatic diseases. Given its long clinical use, further assessment of its safety profile remains relevant. AIM OF STUDY: This study aimed to evaluate the safety profile of meloxicam in the Czech Republic using national pharmacovigilance data, and to compare reported adverse events (AEs) with findings from the WHO VigiAccess database. METHODS: We analyzed all meloxicam-related AEs reported to the State Institute for Drug Control (SUKL) between January 2015 and December 2020, as well as related data extracted from the World Health Organization's pharmacovigilance VigiAccess database. AEs were classified according to MedDRA terminology. National drug utilization data were obtained from SUKL to provide an estimate of meloxicam exposure, expressed in defined daily doses (DDD). RESULTS: Over six years, 24 AE reports were identified in the Czech Republic (population 10.7 million). During the same period, meloxicam consumption reached 71,512,140 DDD, corresponding to 4.64 DDD/1000 inhabitants/day. The most frequently reported AEs were hypersensitivity reactions (10 cases), followed by gastrointestinal events (4 cases), nervous system disorders (4 cases), and isolated cardiovascular toxicity (1 case of heart failure). CONCLUSION: In the context of national exposure, only a limited number of meloxicam-related AEs were reported.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

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Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

NEUROENDOCRINOLOGY LETTERS

ISSN

0172-780X

e-ISSN

2354-4716

Svazek periodika

46

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

SE - Švédské království

Počet stran výsledku

5

Strana od-do

198-202

Kód UT WoS článku

001601128900006

EID výsledku v databázi Scopus

2-s2.0-105021026973