PMID- 29737501
OWN - NLM
STAT- MEDLINE
DCOM- 20181106
LR  - 20181202
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 41
IP  - 9
DP  - 2018 Sep
TI  - Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on 
      Women and Children.
PG  - 835-842
LID - 10.1007/s40264-018-0674-y [doi]
AB  - INTRODUCTION: Although tamsulosin is indicated for the treatment of the signs and 
      symptoms of benign prostatic hyperplasia (BPH), it has also been assessed in 
      clinical studies for other conditions/symptoms and in other populations such as 
      women and children. In this systematic review of randomized studies, the overall 
      safety of tamsulosin was assessed, focusing on these understudied populations. 
      METHODS: Literature searches were conducted using Embase, Medline, and PubMed 
      (inception-December 2015). A study was included if patients were randomized to 
      receive treatment with any dose of tamsulosin capsules, tablets, or an oral 
      controlled absorption system and numerical safety results were reported. RESULTS: 
      Overall, 160 articles involving 46,072 participants met the inclusion criteria. 
      Of these, four studies included women only and three included children. The mean 
      [standard deviation (SD)] age ranged from 7.3 (4.2) to 76.8 (7.1) years. The 
      studies (n; %) evaluated healthy subjects (18; 11%) or patients with lower 
      urinary tract symptoms/BPH (90; 56%), ureteral stones/renal colic (42; 26%), 
      prostatitis (4; 3%), or other conditions (6; 4%). Patients discontinued 
      tamsulosin primarily because of adverse events (AEs) or insufficient response. 
      AEs in women and children were abdominal pain, asthenia, constipation, dizziness, 
      dry mouth, drowsiness, dyspepsia, headache, incontinence, nasal congestion, 
      nausea, orthostatic hypotension, and somnolence. Due to heterogeneity across 
      studies, statistical analysis could not be conducted. DISCUSSION: No unexpected 
      AEs were observed in an all-comers population treated with tamsulosin for various 
      conditions/symptoms. The overall safety profile in women and children seemed to 
      be generally consistent with the profile in men, the indicated population.
FAU - Kaplan, Steven A
AU  - Kaplan SA
AUID- ORCID: 0000-0003-2558-7306
AD  - Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai 
      Health System, New York, United States. steven.kaplan@mountsinai.org.
FAU - Chughtai, Bilal I
AU  - Chughtai BI
AD  - Weill Medical College of Cornell University, New York-Presbyterian Hospital, New 
      York, United States.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Sulfonamides)
RN  - 0 (Urological Agents)
RN  - G3P28OML5I (Tamsulosin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Dizziness/chemically induced/epidemiology
MH  - Drug-Related Side Effects and Adverse Reactions/diagnosis/*epidemiology
MH  - Female
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Sulfonamides/*adverse effects
MH  - Tamsulosin
MH  - Urological Agents/*adverse effects
MH  - Young Adult
EDAT- 2018/05/09 06:00
MHDA- 2018/11/07 06:00
CRDT- 2018/05/09 06:00
PHST- 2018/05/09 06:00 [pubmed]
PHST- 2018/11/07 06:00 [medline]
PHST- 2018/05/09 06:00 [entrez]
AID - 10.1007/s40264-018-0674-y [pii]
AID - 10.1007/s40264-018-0674-y [doi]
PST - ppublish
SO  - Drug Saf. 2018 Sep;41(9):835-842. doi: 10.1007/s40264-018-0674-y.