FDA Approves Xanodyne Pharmaceuticals, Inc.'s Lysteda to Treat Heavy Menstrual Bleeding
Published: Nov 16, 2009
SILVER SPRING, Md., Nov. 13 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.
Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.
"Menorrhagia can be incapacitating for some women," said Kathleen Uhl, M.D., FDA's associate commissioner of women's health. "Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life."
Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.
The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).
Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. 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.
Lysteda is manufactured by Xanodyne Pharmaceuticals of Newport, Ky.
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SOURCE U.S. Food and Drug Administration