Risks of mifepristone abortion in context.

Media attention concerning the recent update to the mifepristone labeling by the US Food and Drug Administration and Danco Laboratories has led to misconceptions about the safety of medical abortion [1]. Three women in the United States have died related to medical abortion with mifepristone (one from a ruptured ectopic pregnancy and two from infection). Approximately 360,000 women have used the drug for this procedure (personal communication, Danco Laboratories, November 18, 2004). Hence, the estimated case-fatality rate for mifepristone abortion is 0.8 deaths per 100,000 procedures (95% confidence interval, 0.2–2.4 by Poisson distribution). This risk is statistically indistinguishable from the risk of death from spontaneous abortion (0.7 per 100,000 miscarriages) [2]. The risk is also comparable to that associated with induced abortion overall (mostly surgical procedures) (0.7 deaths per 100,000 procedures) [3]. The risk of death from either spontaneous or induced abortion, including mifepristone medical abortion, is much lower than that associated with childbirth. In 1997, the pregnancy-related mortality ratio was 12.9 deaths per 100,000 live births [4]. Even in women who are not pregnant, infection of the upper genital tract carries a risk of death [5]. Not all such infections are related to sexually transmitted pathogens; the normal flora of the lower genital tract may be implicated. For example, in married women with only one sexual partner, frequent coitus (defined as six or more episodes per week) is associated with a threefold increased risk of upper genital tract infection compared with coitus less than once per week [6]. In summary, the risk of death associated with medical abortion is remote and virtually identical to that with spontaneous and surgical abortion. These risks are substantially less than the risk of continuing the pregnancy. Septic abortion deaths reveal a common theme: delay in recognizing illness, delay in getting medical help, and delay in beginning treatment [7].