Menorrhagia nonhormonal treatment gets FDA nod

December 1, 2009

After a priority review, the US Food and Drug Administration has approved Xanodyne Pharmaceuticals' formulation of tranexamic acid tablets (Lysteda) for the treatment of cyclic menorrhagia.

After a priority review, the US Food and Drug Administration has approved Xanodyne Pharmaceuticals' formulation of tranexamic acid tablets (Lysteda) for the treatment of cyclic menorrhagia. The nonhormonal product works by stabilizing a protein essential to clotting, thus reducing excessive clot breakdown in the uterus.

Approximately 10% of women of reproductive age in the United States report regular intervals of menstruation, with volume that may exceed 80 mL per cycle.

Commonly reported adverse effects of tranexamic acid tablets may include headache; sinus and nasal symptoms; pain in the back, abdomen, muscles, or joints; muscle cramps; anemia; and fatigue. Women who use oral contraceptives concurrently with tranexamic acid tablets have increased risk of blood clots, heart attack, or stroke.

US Food and Drug Administration. FDA approves Lysteda to treat heavy menstrual bleeding [press release]. November 13, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190551.htm. Accessed November 20, 2009.