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Blood Clotting Drug Lysteda approved by FDA for Treatment of Heavy Bleeding with Menstrual Periods

Posted Nov 15 2009 10:01pm

The state 3 trials were just completed.  The article said use with contraception pills is also not a good idea.  I believe this is one of the first non hormone treatment in a pill format (beyond what Midol can do)  that had been approved to treat menstrual period with heavy bleeding.    This is the same company that markets Darvon, located in Kentucky.  It has been around for a while, but now just refined to address other treatment processes image other than those with blood that does not clot.  I’m not exactly sure how this will work, clot the blood before the bleeding begins?  This is just fresh off the approval list so I’m sure we will hear more.  BD

The U.S. Food and Drug Administration today approved Lysteda tablets ( tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

Heavy menstrual bleeding 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 the condition.

“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., 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 was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used 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.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190551.htm

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