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What is a Medication

Abortion? There are two medication abortion regimens that have a long safety and efficacy record: mifepristone with misoprostol and misoprostol alone. Both involve taking oral medications to terminate a pregnancy.

Mifepristone and Misoprostol Regimen The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol. Mifepristone, also known as the abortion pill, or RU-486 is sold under the brand name Mifeprex and through a generic manufactured by GenBioPro in the United States. Mifepristone works by blocking progesterone, a hormone essential to the development of a pregnancy, and thereby preventing an existing pregnancy from progressing. Misoprostol, taken 24–48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage. A follow-up visit can be scheduled a week or two later, to confirm that the pregnancy was terminated via ultrasound or blood test. The FDA has found that medication abortion is a safe and highly effective method of pregnancy termination. When taken, medication abortion successfully terminates the pregnancy 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).

The FDA first approved Mifeprex in 2000. In 2016, the FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1). Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone.

Misoprostol-Only Regimen While the combined regimen of mifepristone and misoprostol for medication abortion is recommended, there is a second medication abortion protocol using misoprostol–only that is more commonly used internationally and currently not approved by the FDA. The regimen is also recommended for up to 70 days (10 weeks) of pregnancy. It involves taking 800 µg (4 pills) of misoprostol sublingually or vaginally every three hours for a total of 12 pills. Research has shown the misoprostol-only regimen to be a safe and highly effective method of pregnancy termination, however it may result in a higher incidence of side effects, particularly diarrhea, fever and chills. When taken, the misoprostol-only regimen successfully terminates the pregnancy approximately 80-100% of the time, with a complication rate of less than 1%. Some U.S. telehealth organizations have been providing the misoprostol-only regimen as an option for medication abortion for a number of years.