FDA Approves Drug for Menorrhagia, with a Warning

The FDA on Friday announced approval of Lysteda (tranexamic acid) tablets as the first nonhormonal product to treat menorrhagia. It warns, however, that use of the drug while taking hormonal contraceptives may increase the risk for thrombi, stroke, and myocardial infarction.

Tranexamic acid, a derivative of the amino acid lysine, blocks lysine-binding sites on plasminogen, thus blocking fibrinolysis. It was first approved in the 1980s to prevent excessive bleeding during tooth extraction in patients with hemophilia.