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FDA Approves Tranexamic Acid Tablets to Treat Menorrhagia ROCKVILLE, Md -- November 13, 2009 -- The US Food and Drug Administration (FDA) has approved tranexamic acid tablets (Lysteda) to treat menorrhagia. “Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, MD, Women’s Health, FDA, Rockville, Maryland. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.” The most common adverse reactions reported during clinical trials by patients using tranexamic acid a included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. In clinical studies, there was a statistically significant reduction in menstrual blood loss in women who received tranexamic acid, compared with those taking a placebo. Use of tranexamic acid while taking hormonal contraceptives may increase the risk of blood clots, stroke, or myocardial infarction, according to Scott Monroe, MD, Division of Reproductive and Urologic Products, in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take tranexamic acid only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version