Jana Mlíchová, Vojtěch Mészáros, Ondřej Šimandl, Eva Kmoníčková, Dagmar Kalátová, Zoltán Paluch
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Abstract
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 (SÚKL) 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 SÚKL 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.
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