Device to control heavy menstrual bleeding Mirena from Bayer approved in US

Mirena, an intrauterine device to control heavy menstrual bleeding in women, from Bayer has been given approval by US FDA.

Mirena is a hormone-releasing device inserted into a woman’s uterus.

Mirena is a small, white coloured T-shaped plastic system with black threads attached to the vertical arm. Mirena is contained within an insertion device and is provided in a sterile pouch for insertion by a doctor experienced in the insertion of intrauterine systems.

Mirena was approved in 2000, as a contraceptive aid for women. However, US FDA extended he birth control medicine Mirena’s approval to treat heavy menstrual?bleeding in women.

Mirena, originally approved in 2000, is a small hormone-releasing device inserted into a woman’s uterus to prevent pregnancy. The recent approval allows Bayer to say on the drug’s label that it can treat heavy menstrual bleeding.

Clinical trial data on Mirena showed it helped significantly reduce  bleeding. Kathleen Uhl, director of the FDA’s Office of Women’s Health, said in a statement.

Mirena works in the treatment of excessive monthly bleeding by slowly releasing the progestogen hormone levonorgestrel, within the womb. Levonorgestrel suppresses the response of the cells in the lining of the womb to oestrogen making the lining of the womb insensitive to circulating oestradiol. This stops the growth of the lining of the womb, which results in a reduction in the volume and duration of menstrual bleeding.

Mirena’s mechanism of action stops excessive bleeding (menorrhagia) by protecting against over stimulation of the lining of the womb in oestrogen replacement therapy.

Levonorgestrel hormone in Mirena prevents pregnancy by controlling the monthly development of the womb lining so that it is not thick enough for you to become pregnant.

Mirena makes the normal mucus in the cervical canal (opening to the womb) thicker, so that the sperm cannot get through to fertilise the egg.

Mirena slso prevent ovulation (the release of eggs) in some women.

Mirena has local effects on the lining of the womb caused by the presence of the T-shaped frame since Mirena is also an intrauterine contraceptive device by influencing the movement of sperm inside the womb,preventing fertilisation women who suffer from prolonged menstrual bleeding find the condition “unpleasant, disabling and frightening.

Mirena should be inserted either during the menstrual period or within seven days from the beginning of your period. Mirena can be inserted immediately after abortion as long as there are no genital infections. Mirena should not be used until six weeks after delivery.

When Mirena is used to protect the lining of the womb during oestrogen replacement therapy, it can be inserted at any time if the women do not have monthly bleeding or else during the last days of menstruation or withdrawal bleeding.

Some women may feel faint after the system is fitted. In very rare cases during fitting, part or all of the system could penetrate the wall of the womb. If this happens the Mirena needs to be removed.

Women are recommended to wait about 24 hours after having the Mirena inserted to have sexual intercourse.

Side?effects reported with the drug include pelvic?inflammatory?disease and ectopic pregnancy, where a fertilized egg grows outside the uterus.

Other unwanted effects or symptoms which may be due to Mirena include: lower abdominal (tummy) pain especially if the women have missed a period or have unexpected bleeding. This may be a sign of an ectopic pregnancy.

Mirena is recommended for women who have had a child, the FDA said.

Between nine and 14 percent of healthy women suffer from heavy menstrual bleeding, according to a gynecologic survey.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. The 2006 acquisition of Schering was the largest purchase in Bayer’s history.

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading companies in the healthcare and medical products industry and is based in Leverkusen, Germany.

Bayer combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions.