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A Benefit-Risk Review of Systemic Haemostatic Agents

Part 2: In Excessive or Heavy Menstrual Bleeding

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Abstract

The first part of this benefit-risk review examined the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in major surgery. The second part of this review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in the treatment of excessive or heavy menstrual bleeding, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting. Historically, surgery has played a dominant role in treatment; however, pharmacological therapy is increasingly popular, especially in women who wish to retain their fertility. When selecting the appropriate treatment, patient preference should be considered, as well as the benefits and risks associated with each agent. Recommended pharmacological therapies that are effective and generally well tolerated include the levonorgestrel-releasing intrauterine system and the oral agents tranexamic acid, NSAIDs (e.g. mefenamic acid) and combined estrogen/ progestogen oral contraceptives. In patients with an underlying bleeding disorder (e.g. von Willebrand disease), an additional option is intranasal desmopressin.

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Acknowledgements

Funding for the preparation of this manuscript was provided by Daiichi Sankyo Co., Ltd.

Dr Fraser has undertaken consultancies, given lectures for or received honoraria for scientific contributions to meetings for the Daiichi Sankyo, Organon and Schering companies. Dr Porte has previously received an unrestricted research grant from Bayer Pharmaceuticals and is involved in a trial that is co-sponsored by Johnson & Johnson. Dr Kouides serves on the advisory board of CSL Behring (which markets intranasal desmopressin), has been a consultant to the Ferring Pharmaceuticals (which manufactures desmopressin) and serves on the Drug Monitoring Safety Boards of Xanodyne Pharmaceuticals Inc. (which markets ε-aminocaproic acid and is developing a sustained-release form of oral tranexamic acid). Dr Lukes has been an investigator on several trials using tranexamic acid, including the CDC study on heavy periods using tranexamic acid and desmopressin is a consultant to Xanodyne Pharmaceuticals Inc. (who is pursuing FDA approval for tranexamic acid in the US) and has been a speaker forDaiichi Sankyo Co., Ltd (FIGO 2006). Dr Lukes received a small stipend for contributing to this manuscript.

The authors would like to thank Dr Susan Keam, of Wolters Kluwer Health Medical Communications, for her assistance in the writing and editing of this manuscript.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, University of Sydney, Sydney, NSW, Australia

    Ian S. Fraser

  2. Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

    Robert J Porte

  3. Mary M. Gooely Hemophilia Center of Rochester, Rochester, New York, USA

    Peter A. Kouides

  4. Carolina Women’s Research and Wellness Center, Durham, North Carolina, USA

    Andrea S. Lukes

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  1. Ian S. Fraser
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  2. Robert J Porte
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  3. Peter A. Kouides
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  4. Andrea S. Lukes
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Correspondence to Ian S. Fraser.

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Fraser, I.S., Porte, R.J., Kouides, P.A. et al. A Benefit-Risk Review of Systemic Haemostatic Agents. Drug-Safety 31, 275–282 (2008). https://doi.org/10.2165/00002018-200831040-00001

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