Off-label indications for mifepristone in gynecology and obstetrics

The 15th anniversary of the registration of mifepristone in the United States (US) provides an opportunity to reflect on its history, its contribution to women's reproductive health and to consider its promising future as a therapeutic agent. Mifepristone was first approved by the Food and Drug Administration (FDA) as part of a medical regimen to induce abortion in the early first trimester, and most recently in 2012, it was registered in a different formulation as an antiglucocorticoid for the treatment of Cushing's syndrome [1]. Furthermore, years of scientific research have demonstrated the utility of mifepristone for a variety of off-label obstetric and gynecologic indications. Evidence-based alternative use of registered drugs for indications other than those on their approved labels is commonplace in the US and allowable under FDA policy [[2], [3]]. There are numerous examples of registered drugs that are widely used off-label safely and effectively for obstetric and gynecologic conditions, such as misoprostol to induce cervical ripening and uterine contractions, methotrexate to treat ectopic pregnancy, and magnesium sulfate as a treatment for preeclampsia.