Can Mifeprex and misoprostol actually cause serious bacterial infections?
No. A causal relationship between use of the drugs and serious bacterial infection has not been established. There is a risk of infection with any termination of pregnancy, either spontaneous or through medical or surgical abortion. It is important for health care providers to explain the treatment regimen’s risks and benefits to patients, answer their questions and provide them with information about potentially serious signs and symptoms that would signal the need to seek medical attention right away. • Why is prolonged or heavy bleeding now part of the Black Box warnings? In Europe, there was a death from severe prolonged bleeding in a woman who did not seek follow-up medical care. Bleeding during medical abortion is a known side effect and has been in the WARNINGS section of the labeling since the drug was approved. FDA and Danco agree that prolonged or heavy bleeding severe enough to cause a death can be avoided if patients and health care providers monitor bleeding carefully. To
