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. 2023 Jul;62(Suppl2):68-75.
doi: 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  1 , Željana Margan Koletić  1 , Tvrtko Hudolin  2 , Siniša Tomić  1
Affiliations

REVIEW OF ADVERSE DRUG REACTIONS OF MEDICINES USED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA REPORTED TO HALMED

Iva Kuliš et al. Acta Clin Croat. 2023 Jul.

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; Combination of tamsulosin and dutasteride; Combination of tamsulosin and solifenacin; Doxazosin; Dutasteride; Finasteride; Serenoa repens extract; Side effects; Silodosin; Tadalafil; Tamsulosin.

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Figures

Fig. 1
Fig. 1
Number of adverse drug reaction (ADR) reports for benign prostate hyperplasia (BPH) drugs submitted to HALMED from 2008 to 2021.
Fig. 2
Fig. 2
Number adverse drug reaction (ADR) reports for each benign prostate hyperplasia (BPH) drug.
Fig. 3
Fig. 3
Seriousness of reported adverse drug reactions (ADRs) for benign prostate hyperplasia (BPH) drugs.
Fig. 4
Fig. 4
Patient age distribution in adverse drug reaction (ADR) reports for benign prostate hyperplasia (BPH) drugs.
Fig. 5
Fig. 5
Contribution of type of reporter in total number of adverse drug reactions (ADRs) for benign prostate hyperplasia (BPH) drugs.
Fig. 6
Fig. 6
Ten most frequently reported adverse drug reactions (ADRs) for benign prostate hyperplasia (BPH) drugs.
Fig. 7
Fig. 7
Use of benign prostate hyperplasia (BPH) drugs in Croatia in Defined Daily Dose per 1000 inhabitants per day (DDD/1000/day).
See this image and copyright information in PMC

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