Intra Uterine Devices In Heavy Menstrual Bleeding
Posted by Dr.Prahallad Panda on 4th October 2009
This post was in Medpost Today. Put here for your viewing.FDA Expands Indication for IUD
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WASHINGTON — The FDA has approved the levonorgestrel-releasing intrauterine contraceptive system Mirena as the first intrauterine device (IUD) indicated for heavy menstrual bleeding. Approval of the new indication was based on findings during the primary clinical trial of the IUD, during which women using the device, “showed a statistically significant reduction in menstrual blood loss,” said Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. Aside from a small number of patients with small uterine fibroids, none of the participants in the trial had been diagnosed with any medical condition known to cause heavy menstrual bleeding. Common adverse effects during the trial included irregular bleeding or spotting, headache, ovarian cysts, and pelvic pain. The contraceptive is a small, flexible, t-shaped hormone-releasing device inserted into the uterus by a healthcare professional. Serious side effects to the system include:
The device was approved as an IUD contraceptive in 2000. The Mirena system is made by Bayer HealthCare Pharmaceuticals of Wayne, N.J. |
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