Danco Laboratories is planning to seek FDA approval for the use of abortion pill Mifeprex for the treatment of miscarriages, The Wall Street Journal reported Oct. 8.
If approved, the move could widen access for women experiencing miscarriages, as some physicians have been prescribing the drug off-label for that purpose, the report said. The FDA first approved Mifeprex for terminating pregnancies in 2000, initially limiting use to the first seven weeks of gestation. The agency has since eased the restrictions, with use of up to 10 weeks' gestation.
The use of mifepristone, the generic equivalent of Mifeprex, is contentious due to its association with abortion, and supporters argue some physicians hesitate to prescribe it for miscarriage reasons over fear of abortion restrictions in some states. Abortion opponents say such laws are not intended to impede miscarriage care and have said Mifeprex is not required to treat miscarriages, according to the Journal.
Physicians currently most often use misoprostol, a widely available generic drug, when seeking to treat miscarriages with medication. In 2018, the American College of Obstetricians and Gynecologists said physicians should consider using mifepristone, but few do, given the restrictions in some states.
Studies have shown that using mifepristone alongside misoprostol can reduce the need for follow-up surgeries for miscarrying women. For example, a 2018 study published in the New England Journal of Medicine found that 9% of patients who received both medications required surgery, compared to 24% who received misoprostol alone, the report said.