Mifepristone and misoprostol for early medical abortion: 18 months experience in the United States.

In the first 18 months since mifepristone was approved by the Food and Drug Administration (FDA) for use with misoprostol for early medical abortion, approximately 80,000 women have been treated. One-hundred thirty-nine adverse events were reported to Danco Laboratories LLC and subsequently reported to the FDA. Thirteen patients required blood transfusions, 10 patients were treated with antibiotics for infection and 6 had a generalized allergic reaction. Fifty patients had an ongoing pregnancy, with 48 having suction curettage, leaving 2 ongoing pregnancies. Thirty-nine patients had a suction curettage for heavy or prolonged vaginal bleeding. The overall national experience has been highly favorable.