The Medical Letter on Drugs and Therapeutics
In Brief: Expanded Access to Mifepristone
Download PDF:   US English
Med Lett Drugs Ther. 2023 Feb 20;65(1670):31   doi:10.58347/tml.2023.1670c
Principal Faculty
  • Mark Abramowicz, M.D., President has disclosed no relevant financial relationships.
  • Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
  • Brinda M. Shah, Pharm.D., Consulting Editor has disclosed no relevant financial relationships.
Upon completion of this activity, the participant will be able to:
  1. Discuss the availability of mifepristone for medical abortion.
 Select a term to see related articles     Mifegymiso   Mifeprex   mifepristone   misoprostol 

First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies of up to 10 weeks' gestation. A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of the prostaglandin analog misoprostol terminates early intrauterine pregnancies in about 95% of women.

Before the COVID-19 pandemic, mifepristone could be dispensed to a patient only in-person by a certified prescriber. In late 2021, the FDA modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to allow mifepristone to be dispensed by mail by certified prescribers or pharmacies.1 The FDA has now announced that certified retail pharmacies will be permitted to dispense the drug to patients who present a prescription from a certified prescriber.2 To become certified, prescribers and pharmacies must complete agreement forms attesting to certain requirements. The patient is also required to complete an agreement cosigned by the prescriber. Retail pharmacies will not be permitted to dispense mifepristone in states that have passed laws forbidding medical termination of pregnancy.

© The Medical Letter, Inc. All Rights Reserved.
The Medical Letter, Inc. does not warrant that all the material in this publication is accurate and complete in every respect. The Medical Letter, Inc. and its editors shall not be held responsible for any damage resulting from any error, inaccuracy, or omission.
This article has been freely provided.
arrow to previous article
arrow to next article