WebMD Health News
Louise Chang, MD
Nov. 13, 2009 -- The FDA today approved Lysteda tablets (tranexamic acid),
the first non-hormonal product cleared to treat heavy menstrual bleeding
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, according to an FDA news release. Women with uterine fibroids may
experience heavy menstrual periods. But in most cases, there is no underlying
health condition associated with menorrhagia.
"Menorrhagia can be incapacitating for some women,"Kathleen Uhl, MD, the
FDA's associate commissioner of women's health, says in a news release. "Heavy
menstrual periods can cause pain, mood swings, and disruptions to work and
Tranexamic acid isn't a new drug. It was first approved by the FDA in 1986
as an injection under the brand name Cyklokapron. It's 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
The FDA approved Lysteda based on clinical trials in which women took Lysteda
or a placebo. Women taking Lysteda had less menstrual blood loss than women
taking a placebo.
The most common adverse reactions reported during clinical trials by
patients using Lysteda included headache, sinus and nasal symptoms, back pain,
abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue.
Using Lysteda while taking hormonal contraceptives may increase the risk of
blood clots, stroke, or heart attack, according to Scott Monroe, MD, director
of the division of reproductive and urologic products in the FDA's Center for
Drug Evaluation and Research.
The FDA notes that 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 made by Xanodyne Pharmaceuticals of Newport, Ky.
SOURCE:News release, FDA.
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