Pharmacy News Article

2 October 2009 - Bayer HealthCare Pharmaceuticals Inc, the US-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG (ETR: BAYN), announced yesterday that the US 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 USA for this indication.

FDA approval is based on data from a randomised, 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.

Stefan Oelrich, vice president and general manager, Women's Health Care, Bayer HealthCare Pharmaceuticals, said that Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. The company is pleased to now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an IUD for contraception, Oelrich added.

Heavy menstrual bleeding is a problem that affects between nine and 14% of otherwise healthy women 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).

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