What information has FDA received pertaining to adverse events for mifepristone?
Through November 5, 2004, FDA has received information from United States postmarketing reports (i.e., not from clinical trials) of 676 adverse events that occurred among patients who had taken mifepristone for medical termination of pregnancy. These adverse events ranged from minor symptoms such as nausea and dizziness to more serious adverse events, including hospitalization and death. These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use and other possible medical or surgical treatments. Because FDA has eliminated duplicate reports that we have identified and, in some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details, the numbers provided here may differ from the numbers of the reports that may be obtained through Freedom of Information Act requests. Approximately 350,000 women have been treated with
