FDA-Approved Use of Mifeprex (RU-486)

Facts about the abortion pill and ending pregnancy with medications

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On September 28, 2000, the Food and Drug Administration (FDA) announced the approval of RU-486. the controversial drug that is often referred to as the "abortion pill." It is prescribed in the United States by the brand name Mifeprex (mifepristone).

The drug had previously been used in Europe and it was quickly adopted in the United States. Following its approval, the total number of abortions declined by over a quarter million per year from 2001 to 2011.

The number of surgical abortions declined dramatically while the number of medicated abortions grew to make up almost a quarter of the total.

FDA Changes in 2016 for Mifeprex

The clinical experience of the safety of medicated abortion prompted changes to the FDA-approved regimen in 2016 that allows it to be used through 70 days of gestation and do not require in-person visits for the dose of misoprostol and post-treatment assessment. The original FDA label was for use up to 49 days of gestation, which made it an option for 37 percent of abortion patients. The 70-day window makes it an option for 75 percent of abortion patients. The 2016 guidelines also expand who can prescribe the drug.

How Mifeprex is Given

The original rules for RU-486 (Mifeprex) required three visits to a physician's office while the revised guidelines require only one to two visits. The drug can only be prescribed by a physician after a human chorionic gonadotropin (HCG) test, which measures the level of a hormone produced in the body during pregnancy.

Doctors also need to perform a sonogram to confirm and date the pregnancy. The 2016 guidelines allow the medication to be used for up to 70 days of gestation (10 weeks).

Once pregnancy is confirmed, you'll be given two kinds of medication. First, you'll be given one dose of mifepristone, which will make it impossible for a fertilized egg to remain attached to the lining of your uterus.

Originally, the dose was three tablets, but this was reduced to one tablet, taken orally.

The second medication, misoprostol, causes uterine contractions and is taken two days later. The new guidelines allow it to be administered at home as four tablets you place in your cheek rather than swallowing, allowing them to dissolve for 30 minutes. The original guidelines, enforced by some states, required you to visit your doctor to take this second medication.

Misoprostol terminates pregnancy anywhere from six hours to one week later. You must be prepared for cramping and bleeding, which may continue for several days.

Your health care provider must assess your condition seven to 14 days after taking mifepristone. The FDA no longer specifies that this must be an in-person visit. If the pregnancy is still present, a surgical abortion must be performed.

Possible side effects of RU-486 include uterine cramps, fatigue, nausea, and heavy bleeding. Most women recover completely within a few hours to a week. The success rate for medicated abortion is 92 percent to 92.5 percent during the first seven weeks of pregnancy. This leaves a small percentage of women who may require additional surgery.

If you suspect you may be pregnant and you want to use the abortion pill to terminate your pregnancy, you should contact your physician or an area clinic as soon as possible to discuss your options.

Advantages and Disadvantages

The two main advantages of a medicated termination of a pregnancy are its high rate of effectiveness and the fact that it is far less intrusive and painful than a surgical abortion.

As for the disadvantages, Mifeprex may not be an option for women with liver or kidney problems, anemia, diabetes, or those who are overweight. It may not work if combined with other drugs. Side effects can include minor cramping, nausea, vomiting, diarrhea, and bleeding that lasts eight to 10 days.

Changes to the FDA guidelines reflected the practice by many physicians. However, some states had passed legislation requiring strict adherence to the FDA labeling rather than the expanded off-label use.

The change of the labeling may expand access to a medicated abortion.

Sources:

Ending Pregnancy With Medications. MedlinePlus. https://medlineplus.gov/ency/patientinstructions/000835.htm

Jones RK, Boonstra HD. The Public Health Implications of the FDA Update to the Medication Abortion Label. Guttmacher Institute. https://www.guttmacher.org/article/2016/06/public-health-implications-fda-update-medication-abortion-label.

Mifeprex (mifepristone) Information. U.S. Food & Drug Administration. https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm.

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