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 (100.4° 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.
Please see full Prescribing
Information for Mifeprex.