Top

Drug Safety

Published in:

01-09-2018 | Systematic Review

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children

Authors: Steven A. Kaplan, Bilal I. Chughtai

Published in: Drug Safety | Issue 9/2018

Abstract

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.

Available only for authorised users

American Urological Association Guideline. Management of benign prostatic hyperplasia (BPH). American Urological Association Education and Research, Inc. 2010. https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(2010-reviewed-and-validity-confirmed-2014). Accessed 21 June 2017.

Flomax prescribing information. http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Flomax%20Caps/Flomax.pdf. Accessed 21 June 2017.

Campschroer T, Zhu Y, Duijvesz D, Grobbee DE, Lock MT. Alpha-blockers as medical expulsive therapy for ureteral stones. Cochrane Database Syst Rev. 2014;(4):CD008509. https://doi.org/10.1002/14651858.cd008509.pub2.

Chughtai B, Forde JC, Thomas DD, Laor L, Hossack T, Woo HH, et al. Benign prostatic hyperplasia. Nat Rev Dis Primers. 2016;2:16031. https://doi.org/10.1038/nrdp.2016.31.CrossRefPubMed

Schulman CC. Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Expert Opin Drug Metab Toxicol. 2008;4(6):771–82. https://doi.org/10.1517/17425255.4.6.771.CrossRefPubMed

Yuan J, Liu Y, Yang Z, Qin X, Yang K, Mao C. The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews. Curr Med Res Opin. 2013;29(3):279–87. https://doi.org/10.1185/03007995.2013.766594.CrossRefPubMed

Malo C, Audette-Côté JS, Emond M, Turgeon AF. Tamsulosin for treatment of unilateral distal ureterolithiasis: a systematic review and meta-analysis. CJEM. 2014;16(3):229–42.CrossRefPubMed

Velázquez N, Zapata D, Wang HH, Wiener JS, Lipkin ME, Routh JC. Medical expulsive therapy for pediatric urolithiasis: systematic review and meta-analysis. J Pediatr Urol. 2015;11(6):321–7. https://doi.org/10.1016/j.jpurol.2015.04.036.CrossRefPubMedPubMedCentral

Fisher E, Subramonian K, Omar MI. The role of alpha blockers prior to removal of urethral catheter for acute urinary retention in men. Cochrane Database Syst Rev. 2014;(6):CD006744. https://doi.org/10.1002/14651858.cd006744.pub3.

10.

Nickel JC. Role of alpha1-blockers in chronic prostatitis syndromes. BJU Int. 2008;101(Suppl 3):11–6. https://doi.org/10.1111/j.1464-410X.2008.07496.x.CrossRefPubMed

11.

Boyd K, Hilas O. Alpha-adrenergic blockers for the treatment of lower-urinary-tract symptoms and dysfunction in women. Ann Pharmacother. 2014;48(6):711–22. https://doi.org/10.1177/1060028014524174.CrossRefPubMed

12.

Lee KS, Han DH, Lee YS, Choo MS, Yoo TK, Park HJ, et al. Efficacy and safety of tamsulosin for the treatment of non-neurogenic voiding dysfunction in females: a 8-week prospective study. J Korean Med Sci. 2010;25(1):117–22. https://doi.org/10.3346/jkms.2010.25.1.117.CrossRefPubMed

13.

Meyer LE, Brown JN. Tamsulosin for voiding dysfunction in women. Int Urol Nephrol. 2012;44(6):1649–56. https://doi.org/10.1007/s11255-012-0275-0.CrossRefPubMed

14.

Tasian GE, Cost NG, Granberg CF, Pulido JE, Rivera M, Schwen Z, et al. Tamsulosin and spontaneous passage of ureteral stones in children: a multi-institutional cohort study. J Urol. 2014;192(2):506–11. https://doi.org/10.1016/j.juro.2014.01.091.CrossRefPubMedPubMedCentral

15.

Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8(5):336–41. https://doi.org/10.1016/j.ijsu.2010.02.007.CrossRefPubMed

16.

OCEBM Levels of Evidence Working Group. “The Oxford 2011 Levels of Evidence”. Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653. Accessed 10 Mar 2018.

17.

Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 updated June 2010. https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed 21 June 2017.

18.

Hajebrahimi S, Asrbadr YA, Azaripour A, Sadeghi-Bazargani H. Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial. Int J Gen Med. 2011;4:35–9. https://doi.org/10.2147/IJGM.S16063.CrossRefPubMedPubMedCentral

19.

Kim SO, Hwang EC, Oh KJ, Kwon D, Park K, Ryu SB. Efficacy and safety of combined therapy with tamsulosin and tolterodine in female patients with a maximal flow rate less than 12 ml/s. Int Urogynecol J. 2011;22(10):1287–91. https://doi.org/10.1007/s00192-011-1453-9.CrossRefPubMed

20.

Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007;30(2):131–7.CrossRefPubMed

21.

Robinson D, Cardozo L, Terpstra G, Bolodeoku J. Tamsulosin Study Group. A randomized double-blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome. BJU Int. 2007;100(4):840–5.CrossRefPubMed

22.

Aldaqadossi HA, Shaker H, Saifelnasr M, Gaber M. Efficacy and safety of tamsulosin as a medical expulsive therapy for stones in children. Arab J Urol. 2015;13(2):107–11. https://doi.org/10.1016/j.aju.2015.02.007.CrossRefPubMedPubMedCentral

23.

Mokhless I, Zahran AR, Youssif M, Fahmy A. Tamsulosin for the management of distal ureteral stones in children: a prospective randomized study. J Pediatr Urol. 2012;8(5):544–8. https://doi.org/10.1016/j.jpurol.2011.09.008.CrossRefPubMed

24.

Homsy Y, Arnold P, Zhang W. Phase IIb/III dose ranging study of tamsulosin as treatment for children with neuropathic bladder. J Urol. 2011;186(5):2033–9. https://doi.org/10.1016/j.juro.2011.07.021.CrossRefPubMed

25.

Wilt TJ, MacDonald R, Nelson D. Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects. J Urol. 2002;167(1):177–83.CrossRefPubMed

26.

Nickel JC, Sander S, Moon TD. A meta-analysis of the vascular-related safety profile and efficacy of alpha-adrenergic blockers for symptoms related to benign prostatic hyperplasia. Int J Clin Pract. 2008;62(10):1547–59. https://doi.org/10.1111/j.1742-1241.2008.01880.x.CrossRefPubMedPubMedCentral

27.

Karesh K. Pediatric focused safety review: Flomax^® (tamsulosin hydrochloride). U. S. Food and Drug Administration 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM289947.pdf. Accessed 18 October 2016.

28.

Bailey G, Vaughan L, Rose C, Krambeck A. Perinatal outcomes with tamsulosin therapy for symptomatic urolithiasis. J Urol. 2016;195(1):99–103. https://doi.org/10.1016/j.juro.2015.06.097.CrossRefPubMed

Title: Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children
Authors: Steven A. Kaplan
Bilal I. Chughtai
Publication date: 01-09-2018
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 9/2018
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-018-0674-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children

Abstract

Introduction

Methods

Results

Discussion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Discussion

Please log in to get access to this content

Other articles of this Issue 9/2018

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial

Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA)

Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases

Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study

Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis