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FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
Date:10/1/2009

now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an IUD for contraception," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals. "Today's announcement demonstrates our continuing efforts to improve women's health."

Only a woman and her healthcare provider can decide if Mirena is right for her. Mirena is recommended for women who have had a child. Mirena should not be used by a woman who has a pelvic infection, gets infections easily or has certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. A woman should talk to her healthcare provider about problems related to this condition. Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, a woman should use back-up birth control and call her healthcare provider. In the uncommon event a woman gets pregnant while using Mirena, she should seek emergency care because pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility. Pelvic and/or abdominal pain may occur. If persistent, women should talk to their healthcare provider. Ovarian cysts may occur and usually disappear. Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop. Mirena does not protect against HIV or STDs.

About the Heavy Menstrual Bleeding Study

FDA approval is based on data from a randomized, open-label, active-control, parallel-group clinical trial of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause HMB, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of greater than or equal to 80 mL, was determined using the alkali
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SOURCE Bayer HealthCare Pharmaceuticals
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