FDA Approves First Nonhormonal Product for Menorrhagia
By Yael Waknine
Medscape Medical News
November 16, 2009 — The US Food and Drug Administration (FDA) has approved tranexamic acid tablets (Lysteda, Xanodyne Pharmaceuticals) as the first nonhormonal product for the treatment of menorrhagia.
"Menorrhagia can be incapacitating for some women," said Kathleen Uhl, MD, the FDA's associate commissioner of women's health in an agency news release. "Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life."
Tranexamic acid exerts its effects by competitively binding to the lysine receptor sites of plasminogen, thereby helping to normalize the hyperfibrinolytic activity often present in menorrhagia.
The drug's approval was based in part on data from 2 pivotal placebo-controlled phase 3 trials showing that women treated with tranexamic acid experienced a significant decrease in menstrual blood loss relative to baseline during 3 and 6 cycles of treatment (P < .0001 for both).
Adverse events included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle/joint pain, muscle cramps, anemia, and fatigue.
The FDA notes that concomitant use of tranexamic acid with hormonal contraceptives may increase the risk for thrombosis, stroke, and myocardial infarction. Women should only use the products together if there is a strong medical need and potential benefits outweigh therapeutic risks.
Tranexamic acid previously was approved as an injection (Cyclokapron, Pfizer, Inc) for short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and after tooth extraction.
