Important Safety Information
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use. No causal relationship between the use of Mifeprex and misoprostol and these events has been established. A high index of suspicion is needed to rule out serious and rarely fatal infections (e.g. Clostridium sordellii) and sepsis that can present without fever, bacteremia or significant findings on a pelvic exam, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.
Cramping and bleeding are expected; bleeding may continue for 9-16 days. 5-8% of women will need a surgical procedure to end a pregnancy or stop heavy bleeding.
Patients should be counseled to seek immediate medical attention if they experience sustained fever (100.4ยบ F or higher), severe abdominal pain, prolonged heavy vaginal bleeding, syncope or general malaise more than 24 hours after taking misoprostol.
Mifeprex should not be used in cases of confirmed or suspected ectopic pregnancy, as Mifeprex is not effective in terminating these pregnancies. Physicians may need to consider the possibility of a ruptured ectopic pregnancy, even if efforts were made to rule out an ectopic pregnancy, because an ectopic pregnancy may have been missed.