title: A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms.
abstract: OBJECTIVE
  Current guidelines recommend α1-adrenoreceptor blockers (A1Bs) for treating lower urinary tract symptoms suggestive of benign prostatic hyperplasia, but their adverse effects can be problematic. In this study, reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) between 1997 and 2011 were reviewed to assess the safety profiles of A1Bs.
  
  
  METHODS
  After deleting duplicated submissions and revising arbitrary drug names, reports involving A1Bs for male patients were analyzed. Data mining algorisms were used for the quantitative detection of signals, where a signal represents an association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio, reporting odds ratio, information component given by a Bayesian confidence propagation neural network, and empirical Bayes geometric mean.
  
  
  RESULTS
  The total number of reports used was 1,260,182. Signal scores suggested the associations of alfuzosin, doxazosin, tamsulosin, and terazosin with dizziness/vertigo, orthostatic hypotension, erectile dysfunction, ejaculation dysfunction (EjD), thirst/dry mouth, and constipation; however, reports on naftopidil, silodosin, and urapidil were not enough to compare with the other 4 A1Bs. Signal scores for EjD were higher for tamsulosin, and those for dizziness/vertigo were lower for doxazosin than for the other 3 drugs.
  
  
  CONCLUSIONS
  Tamsulosin-associated EjD, which was found in clinical studies, was reproduced in this analysis with markedly higher signal scores, and these results strongly suggest the necessity of well-organized clinical studies on A1B-associated adverse events.
authors.affiliation: Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Kaori
authors.initials: K
authors.lastname: Kadoyama
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sakaeda
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Sugino
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okuno
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D016907:Adverse Drug Reaction Reporting Systems; D001499:Bayes Theorem; D006801:Humans; D008297:Male; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000319:Adrenergic beta-Antagonists
keywords: FAERS; adverse events; pharmacoepidemiology.; α1 blockers