FDA Approves Mirena for 8 Years
The FDA recently approved a supplemental new drug application for Mirena, which extended the use duration by one year for a total of eight years.
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- Alongside Kyleena and Liletta, Mirena is one of three hormonal intrauterine devices (IUD) available in the United States. Previously, the duration of use for Mirena was seven years, at which point the device would be removed or replaced. The recent FDA approval of a supplemental new drug application extended this duration by one year, allowing this form of contraception to be used for eight years. This extension furthers the mission of the We’re For Her Initiative campaign by Bayer Healthcare.
Mirena is a levonorgestrel intrauterine system (LNG IUD). The Mirena website states that the device is more than 99% effective at preventing unwanted pregnancy.
Despite its efficacy, there are some risks associated with Mirena, including abdominal pain, headache, vaginal discharge, ovarian cysts, uterine perforation, infection, and ectopic pregnancy.
According to the Bayer press release, “the contraceptive effectiveness of Mirena after five years of use was studied in 362 women (The Mirena Extension Trial) and was well tolerated with no new or unexpected safety findings. This trial demonstrated contraceptive efficacy greater than 99% during years 6–8 of use.”
This approval comes at a time when access to contraception and women’s reproductive health services is not guaranteed. This additional approval may help extend access to reproductive care.
“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, US Medical Affairs, Bayer Women’s Healthcare, in the Baylor US press release. “A large part of our We’re For Her Mission is helping to ensure education, access, and options. The investment in an 8-year indication will give women who are looking for birth control another option to discuss with their healthcare provider that may meet their needs and personal choice.
The We’re For Her Mission has three main goals: (1) increasing contraceptive access by donating IUDs, (2) collaboration through donations to direct relief, and (3) providing educational tools on contraceptives and reproductive health to underserved populations.
Additional studies must be done on Mirena before the device’s lifespan can be extended any further. Patients considering using Mirena or any other IUD should consult a licensed healthcare professional to discuss risk and schedule an appointment for insertion.
