FDA Extends Mirena IUD for Eight Years of Use

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

The FDA has approved a supplemental new drug application (sNDA) that extends the duration of use of Bayer’s intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) by one more year, making it available to prevent pregnancy for up to eight years.

“Now more than ever, it’s important to help ensure that women have the options they need when it comes to contraception needs at various stages of their reproductive life,” stated Yesmean Wahdan, vice president, U.S. medical affairs, Bayer Women’s Healthcare, said in a press release.

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years by releasing small amounts of progestin hormone called levonorgestrel into the uterus. It also is the only FDA-approved IUD to treat heavy periods for up to 5 years in women who choose intrauterine contraception and can be used in women if they have previously given birth or not.
The approval is based on results from a phase 3 extension trial evaluating the efficacy and safety of Mirena. This trial enrolled in 362 women and demonstrated contraceptive efficacy greater than 99% during years six to year of use.