Lysteda Approved for Heavy Menstrual Bleeding

The FDA has approved Lysteda (tranexamic acid) tablets, the first nonhormonal 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 women of reproductive age in the US. Women with uterine fibroids may experience heavy menstrual periods, but in most cases of menorrhagia, there is no underlying health condition associated with the condition.

"Menorrhagia can be incapacitating for some women," said Kathleen Uhl, MD, the 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 it 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.

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. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda compared to those participants taking placebo.

Use of 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. Women using hormonal contraception should take Lysteda only if there is a strong medical need and if the benefit of treatment outweighs the potential increased risk.

Lysteda is manufactured by Xanodyne Pharmaceuticals.

Contact:
Sandy Walsh
301-796-4669
sandy.walsh@fda.hhs.gov