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Medical Journal Article
Tranexamic Acid Treatment for Heavy Menstrual Bleeding
Andrea Lukes et al.: Obstet Gynecol. 2010 Oct;116(4):865-75.
Tranexamic acid has been used around the world for over 20 years to treat heavy menstrual bleeding. It was recently approved by the FDA in the U.S., and is sold under the trade name LYSTEDA™. In this study 196 women were randomized to receive either LYSTEDA™ or a placebo (sugar pill). 36% of women in each group had fibroids. Menstrual blood loss was measured before any medication and after taking either LYSTEDA™ or the placebo.
Results: Measured blood loss decreased by an average of 40% in women taking LYSTEDA™ and 8% in women taking the placebo. The LYSTEDA™ group also reported a reduction in problems with flooding, leakage, and sexual function. There was little difference in reported side effects between the group that received LYSTEDA™ and the placebo group. One concern with this type of medication is the possibility of blood clots (DVT) forming in other blood vessels in the body, but there were no cases of DVT in the women taking LYSTEDA™. One of the women taking the placebo (who did not take LYSTEDA™) developed a DVT.
Comment: How does LYSTEDA™ (tranexamic acid) work? Menstrual bleeding stops when tiny clots seal blood vessels in lining of the uterus. (These clots are needed to stop bleeding, and are not the large clots you may pass when you’re bleeding heavily.) In addition to materials that form clots there are compounds in menstrual blood (plasmin) that dissolve these clots. When they dissolve too fast excess bleeding occurs (although there can be other causes of heavy bleeding). LYSTEDA™ works by interfering with plasmin production, so the tiny clots needed to stop bleeding do not dissolve too quickly.
76% of women in this study reported decreased bleeding with LYSTEDA™. The beauty of LYSTEDA™ is that you can tell with one cycle if it is going to work for you. If it works the fist cycle it will likely continue working and if it doesn’t it is unlikely to help.
LYSTEDA™ can be used for long term treatment if surgical or other treatment is not needed, or as a temporary measure until definitive treatment can be carried out.
ADDENDUM: May 12, 2011
The FDA has issued a warning about the risk of DVT (blood clots in the legs) and other areas when combined with oral contraceptives, especially in women who are obese or smoke cigarettes. Women in the clinical trials were not taking oral contraceptives so there is no clinical trial data on the risk of combining these with Lysteda™ . There have been US postmarketing reports of blood clots when combining oral contraceptives and Lysteda, particularly in these high risk groups.
The FDA concluded:
Women using hormonal contraception, especially those who are obese or smoke, should use Lysteda only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event. Do not use Lysteda in women who are taking more than the approved dose of a hormonal contraceptive.
Comment: As with any medication, the risks of taking it need to be balanced with the risks of not taking it.