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FDA approves tranexamic acid for heavy menstrual bleeding
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After a priority review, the FDA has announced its approval of tranexamic acid, the first nonhormonal product cleared to treat heavy menstrual bleeding, a condition reported each year by about 3 million women of reproductive age.
“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, MD, the 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 (Lysteda, Xanodyne) was first approved by the FDA more than 20 years ago as an injection (Cyklokapron), used to reduce or prevent bleeding during and after tooth extraction in patients with hemophilia.
The oral drug was approved based on clinical trial data that found a statistically significant reduction in menstrual blood loss in women assigned the drug compared to those assigned placebo.
The most common adverse reactions reported during clinical trials by patients using tranexamic acid included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia and fatigue.
Concomitant use of hormonal contraceptives and tranexamic acid may further exacerbate the increased risk of blood clots, stroke or myocardial infarction known to be associated with hormonal contraceptives. Therefore, although there are no clinical trial data on the risk of thrombotic events with the concomitant use with hormonal contraceptives, 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.
