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. br Mirena as a contraceptive was approved 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. br Women who suffer severe, prolonged menstrual periods condition found unpleasant, disabling and frightening Said Kathleen Uhl, MD, director of the FDA s Office for Women s Health. The bleeding can be so heavy that women have to miss work, school or social activities. br In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss, Said Scott Monroe, MD, director of the Division of Reproductive and Urologic Products at the FDA s Center for Drug Evaluation and Research. br The clinical trial participants 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. br Mirena is recommended for women who have had a child. Clinical studies to support both contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant. br Since its approval in 2000, the most serious adverse reactions in patients using Mirena for any indication include: ectopic pregnancy (pregnancy in which the fertilized egg grows outside the uterus), intrauterine pregnancy (pregnancy with Mirena in place ), group A streptococcal sepsis, an infection called pelvic inflammatory disease; embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. br The most common adverse events reported by patients in the primary 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 pain, and breast tenderness. br br
