What You Need to Know
Mifepristone Safety Overview
For over 15 years, medical evidence has indicated thatmifepristone (Mifeprex Use of mifepristone (Mifeprex®) has been commonly used medications such as over-the-counter non- associated with fewer deaths than Tylenol or steroidal anti-inflammatory drugs and anti-histamines, Viagra, and is safer than full term pregnancy.
and is less risky than continuing a pregnancy to term. In2007, however, anti-choice legislators re-introduced the the use of mifepristone and misoprostol and these events RU-486 Suspension and Review Act, a bill to halt distribution and sale of mifepristone in the US. Despitemifepristone's established safety record, the bill asserts that Comparing Medical Risks of Other
mifepristone "has caused a significant number of deaths,near deaths, and adverse reactions." Medications
Mifepristone is safer than acetaminophen (Tylenol®),
Mifepristone's Safety Is Well-Established
Aspirin®, and sildenafil (Viagra®). Adverse drug events Worldwide, millions of women have used mifepristone for are not uncommon, even with well-accepted and widely safe and effective early abortion. It is approved for use in used medications. For example, accidental 38 countries and has been used for nearly 20 years in acetaminophen overdose is the single most common cause Europe. In the first 18 months after mifepristone approval of catastrophic liver failure in the US, causing in the US, an estimated 80,000 women were treated; 139 approximately 150 deaths annually.3 The American experienced an adverse event.1 These events-including Association of Poison Control Centers reported 59 deaths rash, elevated liver enzymes, medical conditions unrelated from aspirin poisoning in 2003. Estimates of the number to mifepristone use, the need for an aspiration procedure, of excess deaths due to gastrointestinal bleeding from use as well as one death from ectopic pregnancy-occurred of aspirin and other non-steroidal anti-inflammatory at a rate of less than 1% (0.17%, or 170 per 100,000 drugs (such as ibuprofen) range in the thousands.4 From women treated; see table). Of the more than 850,000 US 1993 to 2000, the US Food and Drug Administration women who have used mifepristone for early abortion received over 4,000 adverse event reports, including 55 since its approval nearly eight years ago, seven deaths reports of death, involving loratadine (Claritin®), a drug have occurred, one from a ruptured ectopic pregnancy which recently gained over-the-counter status.5 Among and the others from overwhelming Clostridium infections users of sildenafil, there have been approximately five after women used mifepristone orally and misoprostol deaths for every 100,000 prescriptions provided.6 vaginally (6 cases) and bucally (1 case). One of these According to the manufacturer, Pfizer, more than 23 deaths occurred during a clinical trial in Canada. In five million men worldwide have been prescribed the erectile of the infection cases, the organism was identified as dysfunction medication Viagra and more than 1 billion Clostridium sordellii, an organism which has been seen in rare infections associated with both childbirth andabortion. The sixth case involved infection with Comparing Medical Risks of Continuing
Clostridium perfringens. No causal relationship between Pregnancy to Term
A medication abortion with mifepristone is safer than a
full term pregnancy, which is often associated with
Quick Facts
complications; full-term pregnancy being most risky.
Complications of pregnancy and delivery are common enough that at least 20 to 25% of women require cesarean section, a major surgery. Pregnancy-relateddeaths, including those at delivery, stillbirth, and ectopic pregnancy, claim the lives of two to three US women every day-with 13 deaths reported for every 100,000live births in 1999 (see figure).7 What You Need to Know is a publication of the Association of Reproductive Health Professionals (ARHP) for health care professionals, educators, and researchers working in the field of reproductive health.
Hausknecht R. Mifepristone and misoprostol for early medical abortion: 18 months Distribution of pregnancy-related deaths by
experience in the United States. Contraception 2003;67(6):463-465.
outcome of pregnancy 1991-1999
U.S. Food and Drug Administration. Questions and Answers on Mifeprex(mifepristone). August 2007. Available at www.fda.gov/cder/drug/infopage/mifepristone/qa2007.htm Accessed on February 26, 2008.
Ostapowicz G, Fontana R, Schiodt F, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med McNeil Consumer & Specialty Pharmaceuticals. Aspirin and other OTC NSAIDs Background information for Nonprescription Drugs Advisory Committee Meeting,September 20, 2002.
US Food and Drug Administration. Executive Summary on Risk Issues Draftpresented at joint meeting of the Nonprescription Drugs Advisory Committee andthe Pulmonary - Allergy Drugs Advisory Committee. May 11, 2001.
Mitka M. Some men who take Viagra die-why? JAMA 2000;283(5):5901-5591.
Chang J, Elam-Evans L, Berg C, et al. Pregnancy-related mortality surveillance- United States, 1991-1999. MMWR 2003;52(SS02):1-14.
Patient sought treatment for side effects, Aspiration procedure for bleeding or persistent Continuing pregnancy (requiring aspiration Breast abscess from insect bite resulting in Mifepristone Safety Overview Updated April 2008

Source: https://www.arhp.org/uploadDocs/mifepristonefactsheet.pdf


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