1. Is it safe to use mifepristone?Yes. Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation. The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.
  1. What are the possible side effects of using mifepristone for medical termination of pregnancy through ten weeks gestation?The possible side effects are described in the Adverse Reactions section of the labelingand in the Medication Guide for mifepristone.
  1. What serious adverse events have been reported after the use of mifepristone for medical termination of pregnancy through ten weeks gestation?As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action. This could include, for example, providing updates to health care providers and their patients so that they have information on how to use a drug safely.It is common for the FDA to receive reports of serious adverse events for prescription drugs after they are approved. Many drugs are associated with serious adverse events that are known at the time of approval and considered when the FDA makes its approval decision. The FDA continuously reviews reports of adverse events to, among other things, determine whether they are known risks or whether they are signals of emerging safety concerns.The FDA has received reports of serious adverse events in patients who took mifepristone. As of June 30, 2022, there were 28 reports of deaths in patients associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several fatal cases of severe systemic infection (also called sepsis). The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through June 30, 2022, is here. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report as appropriate.

Full story at fda.gov.