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FDA – Combined Hormonal Contraceptives and the Risk of Cardiovascular Disease Endpoints Public Citizen BMJ: “Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10,” published May 10, 2012 by BMJ. Mother Jones Public Citizen FDA – Combined Hormonal Contraceptives and the Risk of Cardiovasculor Disease Endpoints CBS News MoneyWatch Marie Claire magazine […]
The Mirena IUS is essentially an intrauterine device, or IUD. Its manufacturer calls it an “intrauterine system” because it stops sperm from fertilizing an egg like an IUD, and it stops a fertilized egg from implanting in the uterus. Otherwise, the device is the same T-shape and size of a standard IUD. That is why […]
Bayer HealthCare Pharmaceuticals, Inc., of Montville, New Jersey, manufactures the Mirena IUS / IUD. Bayer HealthCare Pharmaceuticals is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG, a German pharmaceutical and chemical firm that is best known for its aspirin.
The Mirena IUS / IUD is inserted into a woman’s uterus by a doctor to provide long-term birth control. Once in place, it slowly releases a synthetic version of the hormone progestin called “levonorgestrel.” This synthetic hormone thickens the cervical mucus, which blocks sperm from reaching an egg. The hormone also thins the lining of […]
No, there are several reasons a Mirena IUS may not be suitable. The Mayo Clinic says your health care provider may discourage use of Mirena if you: Had or have breast cancer Have uterine or cervical cancer Have liver disease Have uterine abnormalities, such as fibroids, that interfere with the placement or retention of the […]
The U.S. Food and Drug Administration (FDA) says it has received complaints of the Mirena IUS causing pelvic inflammatory disease (PID) and other abdominal and pelvic pain, as well as headache, nausea, uterine bleeding, ovarian cysts, vaginitis, nervousness, depressed libido and depressed mood. PID is an infection of the reproductive organs that can lead to […]
Yes. A more serious problem is that the Mirena IUD tends to move from where it is inserted. This enables the device to embed in the uterine wall or elsewhere in the abdominal cavity or to perforate the uterine wall, intestines or other internal organs. Perforated bowels and other organs can cause infection, including sepsis, […]
In 2008, the FDA approved additions to safety labels on Mirena packaging to include warnings that addressed long-term effects and congenital anomalies, possibility of miscarriage after long-term use of Mirena, cautions about perforation and partial or complete expulsion of the IUD, and a warning against use by breast cancer patients. The FDA sent warning letters […]
Topomax is the brand name of the anticonvulsant drug topiramate. It is sold as a tablet (pill) and prescribed alone or with other drugs to control certain types of epileptic seizures or to prevent migraine headaches. The FDA has approved it for these uses. The FDA says it has also been prescribed “off-label” for other […]