The Food and Drug Administration U.S. today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women using intrauterine contraceptives as a method of preventing pregnancy. This is the intrauterine device first approved by the FDA for this additional indication.Mirena was approved as a contraceptive by the FDA in 2000. This is a small, flexible devicereleasing hormone that is inserted into the uterus to prevent pregnancy. The device must be inserted by a trained medical professional. quot; Women with heavy, prolonged menstrual periods condition found unpleasant, disabling, and aterradorquot, said Kathleen Uhl, MD, director of the FDA Office of Women's Health. quot; The bleeding may be so heavy that women have to miss work, school or activities socialesquot;. quot; In the primary clinical trial, women using Mirena showed a statistically significant reduction in blood loss menstrualquot, said Scott Monroe, MD, director of the Division of Reproductive and Urologic Products at the FDA Center for Evaluation and Research.Participants during the trial had excessive menstrual blood loss before treatment and has no medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.Mirena recommended for women who have had a child. Clinical studies to support both contraception and menstrual bleeding strong indications have excluded women who have never been pregnant.Since approval in 2000, the most serious adverse reactions in patients using Mirena for any indication include: pregnancy ectopic pregnancy (pregnancy in which the fertilized egg grows outside the uterus), intrauterine pregnancy (pregnancy with Mirena in place), a group streptococcal sepsis, an infection called pelvic inflammatory disease; embedment of the device in the uterine wall , and perforation of the uterine wall or cervix.The most common adverse events reported by patients in the pivotal clinical trial using Mirena to treat heavy menstrual bleeding or spotting uterine bleeding at irregular intervals, headache, ovarian cysts , vaginitis, pain during menstruation (dysmenorrhea), pelvic and breast tenderness.Mirena is made by Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ br br
