FOOD AND DRUG ADMINISTRATION

Information on Mifeprex Labeling Changes and Ongoing Monitoring Efforts

FDA initially approved Mifeprex in 2000 and restricted the drug’s distribution to assure its safe use. In 2011, the agency approved a REMS for the drug. In March 2016, FDA approved an application for changes to the indication and dosing regimen for Mifeprex, which were reflected in revised labeling. Other changes included omitting the requirement that the prescriber be a physician. At that time, FDA also made modifications to the REMS. Some have questioned the safety implications of these changes for women using the drug...