TY  - JOUR
AU  - Stević, Ivana
AU  - Janković, Slobodan M.
AU  - Milošević-Georgiev, Andrijana
AU  - Marinković, Valentina
AU  - Lakić, Dragana
PY  - 2024
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5618
AB  - Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization
and even cause death. The aim of this study was to determine the regulatory factors associated
with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines
Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type
and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs
Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological
frameworks. Multivariate statistical analysis was used to investigate the associations of generic
status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment,
orphan drug status, years on the market, administration route, and inclusion on the Essential
Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs
at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately
36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency
are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the
administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs;
the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could
help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.
PB  - Nature Portfolio
T2  - Scientific Reports
T1  - Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure
VL  - 14
IS  - 1
SP  - 9074
DO  - 10.1038/s41598-024-59710-3
ER  - 

@article{
author = "Stević, Ivana and Janković, Slobodan M. and Milošević-Georgiev, Andrijana and Marinković, Valentina and Lakić, Dragana",
year = "2024",
abstract = "Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization
and even cause death. The aim of this study was to determine the regulatory factors associated
with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines
Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type
and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs
Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological
frameworks. Multivariate statistical analysis was used to investigate the associations of generic
status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment,
orphan drug status, years on the market, administration route, and inclusion on the Essential
Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs
at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately
36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency
are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the
administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs;
the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could
help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.",
publisher = "Nature Portfolio",
journal = "Scientific Reports",
title = "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure",
volume = "14",
number = "1",
pages = "9074",
doi = "10.1038/s41598-024-59710-3"
}

Stević, I., Janković, S. M., Milošević-Georgiev, A., Marinković, V.,& Lakić, D.. (2024). Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports
Nature Portfolio., 14(1), 9074.
https://doi.org/10.1038/s41598-024-59710-3

Stević I, Janković SM, Milošević-Georgiev A, Marinković V, Lakić D. Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure. in Scientific Reports. 2024;14(1):9074.
doi:10.1038/s41598-024-59710-3 .

Stević, Ivana, Janković, Slobodan M., Milošević-Georgiev, Andrijana, Marinković, Valentina, Lakić, Dragana, "Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure" in Scientific Reports, 14, no. 1 (2024):9074,
https://doi.org/10.1038/s41598-024-59710-3 . .