What serious adverse events have been reported after mifepristone use?
FDA has received reports of ectopic pregnancy (a pregnancylocated outside of the womb, such as in the fallopian tubes), including one case of ectopic pregnancy resulting in death; several cases of severe systemic infection (also called sepsis), including several deaths; and a single case of non-fatal heart attack. At this time, it is unknown whether there is a causal relationship between any of these events and the use of Mifeprex and misoprostol. In many of these cases, misoprostol was given vaginally, not orally; under the approved regimen, misoprostol is given orally. FDA has not reviewed data on the safety and effectiveness of vaginal administration of misoprostol. As with all approved drugs, when FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, provides updates to doctors and their patients so that they have information on how to use the drug safely. 18. What does FDA know about serious infections reported with Mife
