In 2000, based on clinical trials from both the United States and France, the FDA concluded that “…mifepristone used in combination with oral administration of misoprostol, is safe and effective for the termination of early pregnancy.”

According to the Association of Reproductive Health Providers, “Worldwide, millions of women have used mifepristone for safe and effective early abortion. It is approved for use in 33 countries and has been used for over 15 years in Europe”

The overall risk and complication rate from abortion in general is minimal. In fact, the earlier an abortion is performed, the safer it is for a woman. Since FDA approval six years ago, nearly 600,000 women in this country have chosen an early abortion using mifepristone and misoprostol, rather than a surgical termination.

The deaths of seven women who used the drug have been reported since FDA approval of the drug. In 2004, after three patient deaths, the FDA reaffirmed the overall safety of the medication, but modified its labeling: “The new warnings to health care providers and consumers include[d] changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex.”

In March 2006, after the reporting of several more patient deaths, the FDA announced it was “investigating all circumstances associated with these cases.” To date, the agency has yet to establish a definitive causal relationship between individual mortality and the use of mifepristone.

What has been identified, however, is each woman’s death resulted “from rare bacterial infections” and each used mifepristone. At issue is whether the use of the drug lowered the patient’s immunity, therefore increasing her risk of contracting the infection, whether the drug itself caused the infection, or whether the way the drug is administered caused the infections. There are at least ten other women who experienced the same deadly infections after giving birth or having a miscarriage.

Questions around how the drug has been administered have also been challenged, but the issue was not raised during a recent public review. Still, according to the FDA, going off-label and beyond the recommended regimen “has not been ruled out as a possible factor in the deaths under investigation.”

Based on the above numbers, the overall risk of death associated with medical abortion is about 1 out of 100,000 – about the same rate faced by women experiencing a miscarriage. In comparison, it is lower than the rate of death associated with Viagra, which is 5 out of 100,000 users, and lower than the 13 deaths per 100,000 women associated with childbirth.

Relevant Links:

What is Medical Abortion?

Safety of Abortion

Risk Comparison

New England Journal of Medicine

From the FDA

Fact vs. Fiction: “Abortion Pill” is not the same as Emergency Contraception