FDA OK's heavy menstrual bleeding drug

WASHINGTON, Nov. 16 (UPI) -- The U.S. Food and Drug Administration says it has approved Lysteda tablets (tranexamic acid) as the first non-hormonal drug to treat heavy menstrual bleeding.

The FDA said heavy menstrual bleeding (menorrhagia) is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods, but in most cases there is no underlying health condition associated with menorrhagia.

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

FDA officials cautioned against using Lysteda while taking hormonal contraceptives, since the combination might increase the risk of blood clots, stroke or heart attack. Dr. Scott Monroe, director of the FDA's Division of Reproductive and Urologic Products, said women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

Lysteda is manufactured by Xanodyne Pharmaceuticals of Newport, Ky.