What has happened that made the FDA work with Danco to issue a Dear Doctor Letter?
FDA has been informed of postmarketing adverse events occurring in women treated with Mifeprex and misoprostol. The reports are cases of ectopic pregnancy, which is a pregnancy lodged outside of the womb such as in the tubes, (including one case of ectopic pregnancy resulting in death), severe systemic infection (also called sepsis), and a single case of 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 all of these cases, misoprostol was given vaginally, not orally, which is the approved regimen. FDA has not reviewed data on the safety and effectiveness of vaginal administration of misoprostol. When FDA receives and reviews new information, the agency routinely provides updates to doctors and their patients so that they have information on how to use a drug safely. • What is a ruptured ectopic pregnancy and how often does this happen? An ectopic pregnancy is any pregnancy that develo
