Mifepristone (RU-486): Myths and Facts

December 29, 2000

MYTH: Mifepristone (commonly known as RU-486) is a dangerous drug that will harm women.

FACT: Mifepristone has been proven to be a safe and effective drug.

Mifepristone has been approved for use as a safe and effective abortifacient in 19 countries. The earliest approvals were announced in France and China in 1988, the United Kingdom in 1991, and Sweden in 1992.
Since 1989, more than half a million women in Europe alone have used mifepristone as an early and safe option for ending an unwanted pregnancy.
U.S. clinical trials found that mifepristone, followed two days later by misoprostol (a drug used to stimulate uterine contractions), was a safe and effective abortifacient. For pregnancies of 49 days' or less duration, the drug combination successfully ended pregnancies in 92.1% of the participating patients. In the remaining cases, women experienced continuing pregnancies, incomplete abortions, or other complications and received safe and common first-trimester surgical abortions. Overall, only 0.7% of all participating patients were hospitalized after taking the drugs. Only about half of these hospitalizations were related to the drugs; others were due to unrelated events such as automobile accidents and infectious diseases. There were no deaths reported.
U.S. clinical trials confirmed the findings of studies conducted in France in which thousands of women took mifepristone in combination with misoprostol as an early-option abortion method. The French trials showed the drug combination to be 95.5% effective for ending pregnancies of up to 49 days' gestation.

MYTH: The FDA rushed to approve mifepristone.

FACT: The FDA conducted a rigorous and lengthy review of the drug.

The Population Council submitted its application for mifepristone's approval to the FDA in March 1996, following clinical trials that began in 1983. The FDA issued final approval of mifepristone in September 2000.
The FDA approved mifepristone after carefully reviewing three complete phases of clinical trials-the standard review process-that took place in the U.S. and France and involved thousands of women. Based on the data from these studies, the FDA concluded that the drug is safe and effective.
According to the FDA, the average review time for an "innovative" new drug-unlike mifepristone, which has been extensively tested-is 6 months or less. The agency took considerably more time in approving mifepristone.

MYTH: With mifepristone available, more women will have abortions.

FACT: In countries where mifepristone has been available for many years, the overall abortion rate has not increased. Instead more women have had earlier and, therefore, safer abortions.

Since the drug became available in France in 1989 the total number of abortions has remained constant.
There is no evidence that making medical abortions available to women affects the overall abortion rate. In the 1990s, physicians in the U.S. began to use another safe and effective regime for early medical abortions: methotrexate-misoprostol abortions. The Centers for Disease Control report that in 1997 (the most recent data available), the number of abortions in the U.S. declined to its lowest level since 1978. Moreover, of those women having abortions between 1992 and 1997, more had them in the early weeks of pregnancy.

MYTH: It is dangerous and highly unusual for doctors to use drugs "off-label."

FACT: Evidence-based alternative uses for drugs are standard medical procedure.

A long-standing FDA policy permits medical providers to prescribe medications "off-label," meaning for uses other than those for which a drug has been specifically approved.
According to the American Medical Association, up to 60% of prescription drugs in the United States are prescribed for off-label purposes.
The FDA-approved mifepristone-misoprostol regime calls for doctors to prescribe misoprostol off-label.
Recent studies suggest that mifepristone may be effective in treating fibroid tumors, endometriosis, Cushing's Syndrome, meningiomas, and some types of breast cancer, among other diseases and conditions. It has also been shown to be a safe and effective "morning-after" pill. All of these uses would be off-label.

MYTH: Misoprostol, the second drug in the FDA-approved protocol, is unsafe for use in pregnant women.

FACT: For almost a decade, ob/gyns have used misoprostol safely and effectively in abortions, to assist women in labor, and to treat postpartum complications.

Misoprostol, an anti-ulcer medication, has been widely used off-label in obstetrics and gynecology for almost a decade to ripen the cervix (in abortions and in childbirth), induce labor, and treat serious postpartum bleeding.
Extensive clinical trials have indicated that misoprostol is more effective than and, when used appropriately, as safe as other drugs commonly used to ripen the cervix or induce labor.

MYTH: The Chinese company manufacturing mifepristone for distribution in the U.S. does not meet FDA standards.

FACT: The FDA thoroughly inspected the Chinese factory and determined that the plant fully met FDA standards for international drug distribution.

The Chinese plant contracted to produce mifepristone for distribution in the United States passed a thorough FDA inspection in July 1999.
In the past three years, the manufacturer upgraded its equipment and retrained its staff to meet international standards.