Subject(s)
Abortifacient Agents, Steroidal/adverse effects , Mifepristone/adverse effects , Abortifacient Agents, Steroidal/administration & dosage , Abortion, Induced/legislation & jurisprudence , Female , Government Regulation , Humans , Mifepristone/administration & dosage , United States , United States Food and Drug AdministrationABSTRACT
OBJECTIVE: To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 mug oral misoprostol METHODS: The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 mug misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study RESULTS: Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory CONCLUSION: A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 mug oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration. LEVEL OF EVIDENCE: III.
Subject(s)
Abortion, Therapeutic/methods , Mifepristone/therapeutic use , Misoprostol/therapeutic use , Pregnancy Outcome , Administration, Oral , Adult , Combined Modality Therapy , Dilatation and Curettage , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Follow-Up Studies , Gestational Age , Humans , Logistic Models , Maternal Age , Pregnancy , Probability , Prospective Studies , Risk Assessment , Single-Blind Method , Treatment OutcomeABSTRACT
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.
