New option available for heavy menstrual bleeding

Flip through your patient files from the last week. If you see heavy menstrual bleeding checked several times in your charts, there's a good reason: One-third of all women report such bleeding at some point during their lives.1

Clinicians now have a new treatment option. The Food and Drug Administration (FDA) has approved Lysteda (Xanodyne Pharmaceuticals; Newport, KY), an antifibrinolytic agent, for treatment of heavy menstrual bleeding. The drug, tranexamic acid, is manufactured in 650 mg tablets.

Tranexamic acid likely will be of particular utility for women who desire treatment for heavy menstrual bleeding, but who should or would prefer to avoid hormonal agents, says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. Contraceptive Technology defines heavy menstrual bleeding (menorrhagia) as menstrual periods that occur at regular intervals but are marked by prolonged bleeding (more than seven days) or excessive blood loss (more than 80 cc).2

Medical management options for heavy menstrual bleeding in the United States have included hormonal options and nonsteroidal anti-inflammatory drugs (NSAIDs), says Kaunitz. Hormonal treatments include off-label use of oral contraceptives or injectable depot medroxyprogesterone acetate injections, as well as high doses of oral progestin, such as norethindrone acetate, Kaunitz observes.

The levonorgestrel intrauterine system (LNG IUS, Bayer HealthCare Pharmaceuticals; Wayne, NJ), approved by the FDA for contraception in 2000, has been widely used to treat heavy menstrual bleeding in U.S. women. The Mirena IUS received an FDA-approved indication for such treatment in women who use intrauterine contraception in 2009. Approval of this second indication was based on a pivotal randomized trial demonstrating high efficacy in treatment of the condition,3 says Kaunitz.

Focus on option

Women diagnosed with heavy menstrual bleeding have been found to have higher levels of enzymes that facilitate dissolution of clots (plasminogen activators) in the endometrium in comparison with women with normal menstrual blood loss. Drugs classified as plasminogen activator inhibitors are termed antifibrinolytic agents.

The evidence indicates that tranexamic acid is superior to combined oral contraceptives in reducing heavy menstrual bleeding,4 notes David Grimes, MD, clinical professor in the Department of Obstetrics and Gynecology at the University of North Carolina School of Medicine at Chapel Hill and distinguished scientist at Family Health International in Research Triangle Park, NC. "Tranexamic acid is not as effective in this regard as is placement of a levonorgestrel-releasing intrauterine system,"5 he says. "However, for women who want oral therapy for heavy menstrual bleeding, tranexamic acid is better than what has been used in recent decades."

In unpublished clinical trials, scientists reported statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill.6 The most common adverse reactions reported include headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue.6

In women with normal renal function, the recommended dose is 1,300 mg (two 650 mg tablets) three times daily for a maximum of five days during menstruation. In women with impaired renal function, the dose should be adjusted as detailed in the package insert.7

Use of Lysteda while taking hormonal contraceptives might increase the risk of blood clots, stroke, or heart attack, said Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, in a statement issued at time of the drug's approval.6 Women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk, according to the package insert.7 Suspected adverse reactions may be reported by telephoning Xanodyne Pharmaceuticals at (877) 773-7793 or the FDA at (800) 332-1088, or logging in at the FDA's web site, www.fda.gov/medwatch.

Clinicians might want to consider use of the LNG IUS as a first-line strategy in treatment, if history and other assessments indicate that medical management is appropriate, advise British guidelines.8 Use of tranexamic acid represents a second-line strategy, the British guidelines note.8

References

  1. Miller WB, Shain RN, Pasta DJ. The pre- and post- sterilization predictors of post-sterilization regret in husbands and wives. J Nerv Ment Dis 1991; 179:602-608.
  2. Nelson AL, Baldwin S. "Menstrual Disorders and Related Concerns." In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 19th revised edition. New York City: Ardent Media; 2007.
  3. Kaunitz AK, Bissonnette F, Monteiro I, et al. Levonorges-trel intrauterine system and medroxyprogesterone acetate for treatment of heavy menstrual bleeding. Presented at the Reproductive Health 2009 conference. Los Angeles; Sept. 30-Oct. 3, 2009.
  4. Lethaby A, Farquhar C, Cooke I. Antifibrinolytics for heavy menstrual bleeding. Cochrane Database Syst Rev 2000; CD000249.
  5. Milsom I, Andersson K, Andersch B, et al. A comparison of flurbiprofen, tranexamic acid, and a levonorgestrel-releasing intrauterine contraceptive device in the treatment of idiopathic menorrhagia. Am J Obstet Gynecol 1991; 164:879-883.
  6. Food and Drug Administration. FDA approves Lysteda to treat heavy menstrual bleeding. Press release. Nov. 13, 2009. Accessed at www.fda.gov/NewsEvents.
  7. Xanodyne Pharmaceuticals. Lysteda package insert. Accessed at www.xanodyne.com/pdf/Lysteda.pdf.
  8. National Institute for Health and Clinical Excellence. Heavy Menstrual Bleeding. January 2007. Accessed at www.nice.org.uk/CG44.