Oct. 1, 2009 -- The FDA today approved the intrauterine device Mirena to treat heavy menstrual bleeding in women who use intrauterine contraception as their main form of pregnancy prevention.
Mirena is the first intrauterine device (IUD) approved by the FDA for this additional use.
The FDA approved Mirena as a contraceptive in 2000. Mirena is a small, flexible, hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.
"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," Kathleen Uhl, MD, director of the FDA's Office of Women's Health, says in a news release. "Bleeding can be so heavy that women must miss work, school, or social activities."
Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, notes that in Mirena's main clinical trial, women using Mirena had a reduction in menstrual blood loss.
Participants in that trial had excessive menstrual blood loss prior to treatment and didn't have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.
The FDA notes that Mirena is recommended for women who have had a child, and that clinical trials to support Mirena's use as a contraceptive and to treat heavy menstrual bleeding have excluded women who have never been pregnant.
Since its approval in 2000, the most serious adverse reactions reported in patients using Mirena for any indication include ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus), intrauterine pregnancy (a pregnancy with Mirena in place), streptococcal sepsis (a strep infection that has spread throughout the body), an infection called pelvic inflammatory disease, embedment of the device in the uterine wall, and perforation of the uterine wall or cervix.
The most commonly reported adverse events by patients in the primary clinical trial of Mirena as a treatment for heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness.
Mirena is made by Bayer HealthCare Pharmaceuticals.