IUD Mirena OK'd to Treat Heavy Menstrual Bleeding
Mirena is the First Intrauterine Device Approved by FDA to Treat Heavy Menstrual Bleeding
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
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
"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
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.