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FDA Approves Levonorgestrel IUD to Treat Heavy Menstrual Bleeding
ROCKVILLE, Md -- October 1, 2009 -- The US Food and Drug Administration has approved levonorgestrel intrauterine system (Mirena) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.
"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, MD, the FDA's Office of Women's Health, Rockville, Maryland. "Bleeding can be so heavy that women must miss work, school, or social activities."
"In the primary clinical trial, women using [levonorgestrel intrauterine system] showed a statistically significant reduction in menstrual blood loss," said Scott Monroe, MD, Division of Reproductive and Urologic Products, FDA's Center for Drug Evaluation and Research.
Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.
Levonorgestrel intrauterine system 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.
Since its approval in 2000, the most serious adverse reactions reported in patients using levonorgestrel intrauterine system for any indication include ectopic pregnancy; intrauterine pregnancy; group A streptococcal sepsis; 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 primary clinical trial using levonorgestrel intrauterine system to treat heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, dysmenorrhea, pelvic pain, and breast tenderness.
SOURCE: US Food and Drug Administration
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