Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study. (September 2011)

• Record Type: Journal Article
• Authors: Lukes, Andrea S; Freeman, Ellen W; Van Drie, Douglas; Baker, Jeffrey; Adomako, Tammie L
• Is Part Of: Women's health. Volume 7:Number 5(2011)
• Page Start: 591
• Page End: 598
• Publication Date: 2011-09
• Subjects: competitive plasminogen inhibitor -- heavy menstrual bleeding -- menorrhagia -- safety -- tolerability -- tranexamic acid; Gynecology -- Periodicals; Obstetrics -- Periodicals; Women -- Health and hygiene -- Periodicals; 618.05
• DOI: 10.2217/whe.11.55
• Languages: English
• ISSNs: 1745-5057

Abstract

Aims: An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding.Patients & methods: Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle). Safety was assessed by the incidence of treatment-emergent adverse events, ophthalmologic examinations and ECGs, among other evaluations.Results: The most commonly reported treatment-emergent adverse events were menstrual discomfort (46.2%), headache (43.9%) and back pain (23.1%). A small proportion of participants (3.8%) reported ocular adverse events, but there was no evidence of ocular toxicity. No prothrombotic effects were observed.Conclusion: During nine menstrual cycles of treatment, this novel formulation of TA was well tolerated and exhibited a favorable safety profile supporting its use as a therapy for cyclic heavy menstrual bleeding.