RU - 486 (Commonly referred to as "The Abortion Pill" )
This drug is FDA (Food and Drug Administration) approved for use in women up to 49 days after their last menstrual period; however, it is commonly used "off label" up to 63 days. (1) The FDA-approved procedure usually requires three office visits. On the first visit, the woman is given pills (mifepristone) that cause the death of the embryo. Two days later, if the abortion has not occurred, she is given a second drug (misoprostol) which causes cramping that expels the embryo. Most often if the procedure was effective, you will see the expelled embryo. At your last visit, a doctor will perform a physical exam to ensure that your pregnancy was terminated. (2)
Risks associated with medication abortion (Mifeprex/Mifepristone, RU486 with Misoprostol):
- Bleeding: Vaginal bleeding lasts for an average of 9 - 16 days; 1 in 100 women bleed enough to require surgery (D&C) to stop the bleeding. (3)
- Infection: According to the FDA, "Cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported."(4) This means that some Mifeprex users have died as a result of total body infection. The FDA issued a health advisory July 19, 2005 and changed safety labeling to warn of the risk of this serious bacterial infection. (5,6)
- Undiagnosed ectopic (tubal) pregnancy: The abortion pill will not work in the case of an ectopic pregnancy where the embryo lodges outside the uterus, usually in the fallopian tube. If not diagnosed early, there are significant risks exists, (rupture of fallopian tube, internal hemorrhaging and possibly death). (7)
- Failed abortion: The mifepristone-misoprostol regimen fails in 8% of uses in pregnancy up to 49 days gestation, 17% at 50-56 days gestation, (8,9) and 23% at 57-63 days gestation. A surgical abortion is usually done to complete a failed medication abortion. (3,9 pp 111-34)
- Risk of fetal malformations: Research associates the use of misoprostol during the first trimester with certain types of birth defects among medication abortion "failures" (10)
- Continuation of pregnancy: Women who change their minds after beginning a medication abortion and want to continue their pregnancies should immediately seek the help of an obstetrician.
This drug is FDA-approved for treating certain cancers and rheumatoid arthritis, but is used "off-label" to treat ectopic pregnancies and to induce abortion. It works by stopping the growth of rapidly dividing cells. It is used up through 49 days of pregnancy and given orally or by injection. Three to seven days after methotrexate is taken, misoprostol (the second medication used in the RU-486 abortions) is used vaginally.
Side effects of methotrexate include mouth ulcers, lower white blood cell count, nausea, abdominal distress, fatigue, chills, fever, dizziness, decreased resistance to infection and anemia. Severe, sometimes fatal, bone marrow suppression and intestinal toxicity have been reported. Liver toxicity and cancer may occur (usually after prolonged use). Severe, occasionally fatal, skin reactions have been reported. (11)
This form of medication abortion uses only the second drug given in the RU-486 method. It is typically inserted vaginally, requires repeated doses and has a significantly higher failure rate than the RU-486 method. It is associated with nausea, vomiting, diarrhea, and with potential birth defects (central nervous system and limb defects) in pregnancies that continue.
- U.S. Food and Drug Administration. Mifepristone questions and answers 4/17/2002. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyinformationforPatientsandPro viders/ucm111354.htm
- U.S. Food and Drug Administration. Mifeprex medication guide. How should I take mifeprex? Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf
- U.S Food and Drug Administration. Mifeprex package insert. Vaginal Bleeding. Available at: http://www.accessdata.fda.gov.drugsatfda_docs/label/2005/020687s013lbl.pdf
- U.S. Food and Drug Administration. Mifeprex package insert. Infection and sepsis. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf
- U.S Food and Drug Administration. Mifeprex package insert. Boxed warnings. Available at: http://www.accessdata.fda.gov/drugsafda_docs/label/2005/020687s013lbl.pdf
- U.S. Food and Drug Administration. FDA issues public health advisory for mifepristone. Available at: http://www.fda.gov/NewsEvents/Newsrooms/PressAnnouncements/2005/ucm108462.htm
- U.S Food and Drug Administration. Mifeprex package insert. Ectopic pregnancy. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/lable/2005/020687s013lbl.pdf
- Spitz IM, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl.J. Med 1198;338(18)1241-7
- Paul M. Lichtenberg S, Borgatta L, Grimes DA, Stubblefield PG, Creinin MD, eds. Management of unintended and Abnormal Pregnancy, Comprehensive Abortion Care. UK: Wiley-Blackwell; 2009
- U.S Food and Drug Administration. Mifeprex medication label. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/0206087s013lbl.pdf
- Physicians Desk Reference. Methotrexate. Concise monograph. Available at http://www.pdr.net/drugpages/concisemonograph.aspx?concise=589
- Physicians Desk Reference. Cytotec (Misoprostol) Concise monograph Available at: http://www.pdr.net/drugpages/concisemonograph.aspx?concise=1380
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