FDA OKs Menstrual Drug Lysteda

Nov. 13, 2009 -- The FDA 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, 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 family life."

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 blood-clotting factor.

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.