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

WAYNE, N.J., Oct. 1 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Mirena® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena provides an effective, non-surgical option for the treatment of heavy menstrual bleeding and is the first and only contraceptive approved in the U.S. for this indication.

Heavy menstrual bleeding is a problem that affects between nine and 14 percent of otherwise healthy women(1) and is a common reason a woman sees her doctor. Heavy menstrual bleeding is defined as menstrual cycles with 5 tablespoons or more of blood loss (> 80 mL). Signs of heavy menstrual bleeding include:

  • the need to use double sanitary protection to control the heavy flow
  • menstrual flow that soaks through one or more sanitary pads or tampons every hour
  • the need to change sanitary protection during the night(2)

"Many women with heavy periods often suffer privately with their symptoms. And because approved effective non-surgical treatment options are limited, women who do seek treatment for heavy periods often face the choice of having surgical procedures, such as hysterectomies" said Dr. Andrew Kaunitz, M.D., FACOG, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. "In a clinical trial, nearly nine out of 10 women were treated successfully for heavy menstrual bleeding with Mirena -- meaning it reduced monthly blood loss by more than 50 percent from baseline and to below 80 milliliters. This makes it an effective, nonsurgical first-line option."

"Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. We are pleased to
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SOURCE Bayer HealthCare Pharmaceuticals
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