WASHINGTON, Oct. 5 (UPI) -- The U.S. Food and Drug Administration say it has approved Mirena to treat heavy menstrual bleeding in women who use intrauterine contraception.
The approval of Mirena (levonorgestrel-releasing intrauterine system) marks the first intrauterine device approved by the FDA for the additional indication.
Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained healthcare professional.
"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Dr. Kathleen Uhl, director of the FDA's Office of Women's Health. "Bleeding can be so heavy that women must miss work, school, or social activities."
Dr. Scott Monroe, director of the FDA's Division of Reproductive and Urologic Products said in the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss.
Mirena is recommended for women who have had a child. Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant.
Mirena is made by Bayer HealthCare Pharmaceuticals Inc. of Wayne, N.J.