| アブストラクト | PURPOSE: The aim of this study was to analyze the cases of gynecomastia associated with alpha1A-adrenergic receptor antagonists (alpha1-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase()), focusing on tamsulosin use. METHODS: We analyzed the spontaneous reports of gynecomastia related to the use of alpha1-ARAs and collected from the RNF and from VigiBase() up to December 2012. Cases of gynecomastia have been defined as reports associated with gynecomastia according with Medical Dictionary for Regulatory Activities (MedDRA). Reporting odds ratio (ROR) and Information Component (IC) were calculated as measures of disproportionality in RNF and VigiBase(), respectively. RESULTS: Up to December 2012, about 186,000 reports were recorded in the RNF. Among these, 902 reports of adverse drug reaction (ADR) have been associated with the use of at least one alpha1-ARAs. Of these, in 15 cases, gynecomastia was a listed ADR: in 10, the suspected drug was tamsulosin (in eight, it was the sole suspect); in two, doxazosin and alfuzosin, respectively; and in one, terazosin. ROR for tamsulosin was 5.3 (95% CI 1.8, 15.7). In VigiBase(), 84 reports of gynecomastia indicated tamsulosin as suspected drug. Tamsulosin-associated gynecomastia showed the highest IC value within this class of drugs (IC 95% 2.43). CONCLUSION: In this study, we highlight a possible association between gynecomastia and tamsulosin use. To our knowledge, this association has not been described before and could represent a potential signal. |
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| ジャーナル名 | European journal of clinical pharmacology |
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| Pubmed追加日 | 2014/6/4 |
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| 投稿者 | Viola, Ermelinda; Opri, Sibilla; Moretti, Ugo; Leone, Roberto; Casini, Maria Luisa; Ruggieri, Sara; Minore, Claudia; Conforti, Anita |
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| 組織名 | Pharmacology Unit and Pharmacovigilance Centre of Veneto Region, University;Hospital, P.le L.A. Scuro, 10, 37134, Verona, Italy, ermelinda.viola@univr.it. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24888880/ |
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