Analiza sigurnosnog profila TNF-a inhibitora na temelju zaprimljenih prijava sumnji na nuspojave u 2018. i 2019. godini

Professional paper - Professional paper

• Author: Lucija Kanižaj
• Author: Nikica Mirošević Skvrce
• Author: Maja Ortner Hadžiabdić
• Author: Željana Margan Koletić
• Author: Siniša Tomić
• Author's institution: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Centre for applied pharmacy)
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract (english)

The aim of this study was to analyze the adverse drug reactions
of TNF-a inhibitors reported to the Agency for Medicina! Products
and Medica! Devices of Croatia in the period from 1 January 2018 to 31
December 2019, and to raise awareness of the safety profile of these drugs and
risk minimization measures, especially additional measures. Reports of suspected
adverse reactions were analyzed according to: reporter qualification, age and
sex of the patient, suspected drug, concomitant drugs, seriousness of reaction,
System Organ Class using the Medical Dictionary for Drug Regulatory Affairs
(MedDRA). Total of 246 ADR (Adverse drug reaction) reports were analyzed.
Majority of patients belonged to the age group 45-64 years (39.4 %) and were
female (60.6 %). ADRs were in most cases reported by physicians (86.2 %). The
most frequent suspected active substances were infliximab and adalimumab,
while concomitant substances the most often belonged to the group of immunosuppressants
and analgesics. Of all received ADR reports, 61 % were serious.
Majority of ADRs belonged to System Organ Class "General disorders and
administration site conditions" and the most commonly reported preferred tem
was "drug ineffectiveness''. The obtained results can improve prevention, detection
and treatment of possible adverse reactions.

• Keywords (croatian): TNF inhibitori; nuspojave lijekova; farmakovigilancija
• Language: croatian
• Publication type: Professional paper - Professional paper
• Publication status: Published
• Peer review: Peer review - domestic
• Publication version: Published version
• Journal title: Farmaceutski glasnik
• Numbering: vol. 78, no. 7-8, pp. 337-348
• p-ISSN: 0014-8202
• URN:NBN: urn:nbn:hr:163:319517
• Publication: 2022
• Type of resource: Text
• Access conditions: Open access
• Created on: 2022-09-07 15:48:27