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Fatal Sepsis in Women Undergoing Medical Abortion

When considering the FDA’s recent alert, clinicians should note that the case-fatality rate with medical abortion is similar to that with spontaneous or surgically induced abortion, and lower than that with childbirth.

In July 2005, the FDA issued an Alert for Healthcare Professionals following four reports of fatal sepsis among U.S. women after medical abortion with mifepristone (Mifeprex) and misoprostol. All four cases, which occurred in California from September 2003 to June 2005, involve the off-label dosing regimen of 200 mg of oral mifepristone followed by 800 µg of intravaginal misoprostol. Although this regimen has been reported to be effective (Journal Watch Women’s Health Jun 21 2005), the FDA-approved protocol calls for 600 mg of oral mifepristone followed 48 hours later by 400 µg of oral misoprostol (approved for use through 49 days’ gestation).

The organism causing sepsis has been identified as Clostridium sordellii in two of the cases; the other two cases remain under investigation. The two women with confirmed C. sordellii sepsis did not have fever; however, they did have weakness along with nausea, vomiting, or diarrhea, with or without abdominal pain. Both had leukocytosis and hemoconcentration.

Comment: When considering the FDA’s alert, clinicians and patients should keep in mind the following: Since FDA approval of mifepristone in fall of 2000, more than 460,000 women in the U.S. have used this agent for medical abortion (written communication from the manufacturer, July 18, 2005) — and the case-fatality rate is approximately 1 death per 100,000 procedures. This rate is similar to that associated with spontaneous abortion or surgically induced abortion. In contrast, the risk for maternal death associated with childbirth is considerably higher — 12.9 deaths per 100,000 live births in the U.S. in 1997 (Obstet Gynecol 2003; 101:289). In addition, fatal postpartum C. sordellii infections have been reported (Am J Obstet Gynecol 1989; 161:987).

The FDA advises healthcare providers to be alert to the possibility of sepsis in patients who have undergone medical abortion and who present with weakness plus nausea, vomiting, or diarrhea, with or without abdominal pain. A complete blood count can be critical in identifying patients with bacterial infection. In this setting, immediate treatment with antibiotics effective against anaerobes is appropriate (e.g., metronidazole). This advice holds not only for women who have undergone medical abortion, but also for all women who have recently been pregnant.

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health August 2, 2005