"Analysis of the pivotal trials revealed that the average bleeding time was 10.8 days including 2 days of heavy bleeding. The majority of adverse events reported were transient and mild to moderate in severity. The medication causes vaginal bleeding and commonly induced pain and cramping, which required pain medication in some women. The other adverse events more commonly reported were diarrhea, nausea, vomiting, fever/chills, headache, dizziness and weakness. Treatment failure (which was defined as viable pregnancy, non-viable persistent pregnancy, persistent bleeding and abdominal pain that required a surgical termination of pregnancy) was reported in 2% to 4.8% of women.
A small number of patients who took Mifegymiso presented more serious complications, such as pelvic infections (endometritis, salpingitis [inflammation of the fallopian tubes]) and vaginal haemorrhages. Rare cases of fatalities were reported, therefore access to emergency care which can provide gynaecological surgical procedures, antibiotic intravenous therapy and blood transfusion in the rare cases where complications occur, is recommended in the labelling to ensure patient’s safety."