August 13, 2021

The U.S. FDA has expanded approval for Mirena® (levonorgestrel-releasing intrauterine system), an intrauterine device (IUD) manufactured by Bayer, to prevent pregnancy. Previously approved for use up to six years for this indication, the IUD can now be kept in place up to seven years.

Mirena prevents pregnancy by slowly releasing levonorgestrel over time from a small device placed inside the uterus. Levonorgestrel is a type of progestin hormone that prevents pregnancy by reducing ovulation and by making it more difficult for sperm to reach and fertilize eggs.

In a clinical trial, Mirena was effective at preventing pregnancy during a seventh year of use. Under the recommended dosing, a Mirena IUD should be inserted by a trained healthcare provider using strict aseptic technique. Once the IUD has been placed, the patient should be re-examined and evaluated four to six weeks following insertion, then yearly or more often if clinically indicated. Mirena should be removed by a qualified healthcare provider at the end of its use. A new Mirena IUD can be placed immediately following removal of the old one if the patient wishes to continue using the product for contraception.

First FDA approved in 2000, Mirena is also indicated for use for up to five years to treat heavy menstrual bleeding in females who choose to use intrauterine contraception as their method of contraception.

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