FDA expands approval of Mirena for up to 8 years

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for an extension of Mirena (levonorgestrel-releasing intrauterine system) 52 mg Intrauterine Device (IUD) for an additional year, extending the number of years it can be used to prevent pregnancy to 8 years.

The approval follows a phase 3 trial which analyzed the effectiveness of Mirena in 362 women who have used the product for over 5 years. Contraceptive efficacy was over 99% from 6 to 8 years of use, and no new safety findings were found.

Mirena releases the hormone levonorgestrel into the uterus to prevent pregnancy and can treat heavy periods for 5 years in women who take intrauterine contraception.

In the year 2000, it was the first hormonal IUD approved for use in the United States. Women can use Mirena whether they have previously given birth or not, and it is a long-acting reversible contraceptive that a healthcare provider can remove at any time.

“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,” said YesmeanWahdan, Vice President, US Medical Affairs, Bayer Women’s Healthcare. Wahdan also stated that the company’s We’re For Her Mission will help give women more education, access, and options for contraception needs.

Mirena should not be used by individuals with genital infections or certain cancers. Women experiencing persistent pelvic or stomach pain while on Mirena, or whose Mirena comes out, should call a healthcare provider.

Reference

FDA label update reflects bayer’s commitment to providing options for long-acting contraception. Business Wire. August 18, 2022. Accessed August 22, 2022. https://www.businesswire.com/news/home/20220817005818/en/FDA-Label-Update-Reflects-Bayer%E2%80%99s-Commitment-to-Providing-Options-for-Long-acting-Contraception