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FDA Approves Oral Treatment For Menorrhagia


 

The Food and Drug Administration has approved Lysteda a proprietary form of tranexamic acid, for the treatment of menorrhagia.

According to the FDA, Lysteda, made by Xanodyne Pharmaceuticals, is the first nonhormonal product approved for heavy menstrual bleeding.

Menorrhagia affects about 3 million women a year. It is often caused by uterine fibroids, but often has no underlying cause.

The FDA approved an injectable form of tranexamic acid in 1986 to reduce or prevent bleeding during and following tooth extraction in people with hemophilia. Lysteda is an oral formulation.

The agency cautioned against using Lysteda in conjunction with oral hormonal contraceptives because of an increased risk of blood clots, stroke, or myocardial infarction.

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