Original scientific paper
https://doi.org/10.20471/acc.2023.62.s2.10
Review of Adverse Drug Reactions of Medicines used for the Treatment of Benign Prostatic Hyperplasia Reported to Halmed
Iva Kuliš
; Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Zagreb, Croatia
*
Željana Margan Koletić
; Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Zagreb, Croatia
Tvrtko Hudolin
; Department of Urology, Zagreb University Hospital Center, Zagreb, Croatia
Siniša Tomić
; Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Zagreb, Croatia
* Corresponding author.
Abstract
Benign prostatic hyperplasia is one of the most common diseases in men, with a
prevalence rate of 50% in their 50s to 80% in their 80s, and is mostly treated with chronic drug therapy.
The aim of this study was to analyze adverse drug reactions (ADR) to drugs used in benign prostate
hyperplasia (BPH) treatment reported to HALMED from 2008 to 2021. Data on ADR reports in
Croatia were obtained from the VigiFlow national database and on the use of drugs for BPH in Croatia
from Drug Utilization Reports from HALMED. In the observed period, the number of reports on each
BPH drug, total number of reports, seriousness of reported ADR, patient age and sex, type of reporter,
and most reported ADRs were analyzed. Results showed that 438 ADR reports were received, of which
45.95% on tamsulosin as the most frequently used drug for BPH. Of all reports, 84% were non-serious,
96% were reported in men and 82% in patients older than 45 years. The most frequently reported ADRs
were consistent with the known safety profile of BPH drugs. Pharmacists were the most common (47%)
reporters of ADRs for BPH drugs, while 33% were reported by physicians. Analysis of the reported
ADRs showed that most frequently reported ones were in line with the known safety profile of BPH
drugs. However, given the prevalence of the disease and the extent of the use of BPH drugs, it could be
argued that the number of reports could be higher (i.e., 34 reports/year). Reporting on ADRs is necessary
to better understand the safety profile of drugs in the post-authorization period, and more information
on the safe use of medicines could be collected by raising awareness of healthcare professionals.
Keywords
Benign prostate hyperplasia; Tamsulosin; Combination of tamsulosin and solifenacin; Combination of tamsulosin and dutasteride; Side effects
Hrčak ID:
309195
URI
Publication date:
31.7.2023.
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