Abstract
Heavy menstrual bleeding (HMB) seriously impacts physical and mental well-being of many women during their lifetimes. Many women turn to primary care providers or gynecologists seeking relief and resort to invasive surgical procedures such as endometrial ablation and/or hysterectomy. Pharmaceutical agents (e.g., progestogens, combined oral contraceptives, nonsteroidal anti-inflammatory drugs, hormone-releasing intrauterine devices and hemostatic agents) are all options for women who wish to avoid risks inherent to surgery, maintain fertility and limit the potential for early onset of menopausal symptoms. The response to these agents can be unpredictable and may depend on clinical- and patient-related factors. Agents with a contraceptive effect are not appropriate for women wishing to conceive. Tranexamic acid, an antifibrinolytic, has been used worldwide for over 50 years to effectively treat HMB, but a modified immediate-release formulation was only recently approved in the USA as the only approved treatment option for HMB compatible with fertility and conception.
Financial & competing interests disclosure
D Archer receives or has received research support from Bayer Healthcare, Duramed, Organon, Warner Chilcott, Watson Pharmaceutical and Wyeth Laboratories/Pfizer. He has consulted for Abbott Laboratories, Agile Therapeutics, Bayer Healthcare, CHEMO, Corcept, Ferring Pharmaceuticals, Merck, Schering Plough, Organon and Wyeth Laboratories/Pfizer, and has participated in speaker programs for Bayer Healthcare, Ferring Pharmaceuticals, and Wyeth Laboratories/Pfizer. I Fraser receives or has received research support from Bayer Healthcare and Merck/MSD. He has consulted for Bayer Healthcare, Merck/MSD and Vifor Pharmaceuticals, and has participated in speaker programs for Bayer Healthcare, Daiichi Sankyo, Merck/MSD and Vifor Pharmaceuticals. The authors thank Crystal Murcia, PhD; Jill McCollam, PharmD; and Lamara D Shrode, PhD, ISMPP Certified Medical Publication Professional™, of The JB Ashtin Group, Inc., for their assistance in preparing this manuscript for publication based on the authors’ input and direction. Financial support for editorial assistance was provided by Ferring Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Key issues
• Heavy menstrual bleeding (HMB) affects health and quality of life for many women of childbearing age and carries high costs to the individual and society.
• Women who experience HMB report anxiety, embarrassment, inconvenience and interference with daily activities, which often prompts them to seek medical attention.
• Medical therapy is considered a first-line treatment option and should be explored before use of other invasive surgical interventions.
• TA, a competitive plasmin inhibitor, has a long history of effective use for the treatment of HMB.
• TA has the advantage of short-term usage, given only during the days of each menstruation.
• Prospective, randomized, placebo-controlled, multicenter studies are limited; however, accumulated evidence supports tranexamic acid (TA) as an efficacious and well-tolerated nonhormonal medical therapy option for the treatment of HMB in women wishing to maintain fertility.
• Reductions in MBL with TA treatment are also observed in women with an IUD or with dysfunctions of hemostasis.
• TA has proven effective for improving patient quality of life in addition to reducing MBL.
• The most common side effects associated with TA therapy were minor and infrequent and include headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.
• Risk of thrombosis or visual disturbances are very low based on 50 years of clinical experience and evidence from both short- and long-term clinical studies and occurred at similar rates of occurrence as controls.