Bayer’s levonorgestrel-releasing intrauterine system 52 mg intrauterine device (IUD) (Mirena) is now approved for an extended duration of use for an additional year, making it available to prevent pregnancy for up to 8 years. Previously, this IUD was approved for 7 years of contraception. It is also the only FDA-approved IUD to treat heavy periods for up to 5 years in women who choose intrauterine contraception, and it can be used in women regardless of whether they have previously given birth.
The approval was based on the results of a phase 3 extension trial evaluating the efficacy and safety of the IUD. The trial showed that it was well tolerated, with no new or unexpected safety findings, and demonstrated contraceptive efficacy greater than 99% during years 6 to 8 of use.
For full prescribing information, consult product labeling.