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# Miscarriage Management Needed on Mifeprex Label: Petititon
- URL: https://www.fdaweb.com/miscarriage-management-needed-on-mifeprex-label-petititon/
- Published: 2022-10-07T12:00:00.000Z
- Updated: 2026-09-14T18:02:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152919

The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations have petitioned FDA to ask Danco Laboratories to submit a supplemental NDA for Mifeprex (mifepristone), indicated for medical termination of pregnancy, to add “miscarriage management” to the drug’s indication. The petition also asks the agency to eliminate or modify mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) so that it is not unduly burdensome for that use. “In the meantime, petitioners also request that FDA immediately exercise enforcement discretion with respect to the use and distribution of mifepristone for miscarriage management without complying with the REMS,” the [petition](https://downloads.regulations.gov/FDA-2022-P-2425-0001/attachment%5F1.pdf?ref=fdaweb.com) says.

In their petition, the health groups say that miscarriage management should be added to the mifepristone label because it is the most effective regimen for this. “Published research demonstrates that mifepristone is safe and effective for this use throughout the first trimester (13 weeks and 6 days of pregnancy),” it says. “Indeed, it is as safe or safer than alternatives for miscarriage management and the most effective medical option to manage miscarriage. Patients choosing medical management of miscarriage should have access to the most effective protocol, which is mifepristone in combination with misoprostol.

The petition contends that because of the “onerous restrictions currently in place on mifepristone in the U.S., the most-commonly used medical protocol for miscarriage management today is misoprostol alone. However, leading professional organizations encourage the use of adjunctive mifepristone whenever possible.”