Is Medical Abortion Safe? The FDA performs under pressure

Six years after American women finally won the right to choose a medical abortion, the procedure has once again become controversial. In the last few years, six women have died shortly after a medical abortion due to severe infections of the bloodstream (sepsis). Another mifepristone user died as a result of an ectopic pregnancy.

Although NWHN originally questioned the safety of using hormones to terminate a pregnancy, we quickly became strong advocates for the Food and Drug Administration's (FDA) approval of mifepristone, the French abortion pill originally known as RU-486. Mifepristone and another medication, misoprostol, are used together to cut off the hormone supply necessary for early pregnancy to continue and stimulate a miscarriage. Mifepristone had to meet a high standard to be approved in the U.S., since early abortion performed by the standard technique (outpatient vacuum aspiration) has the lowest complication rate of any commonly performed operation.

The anti-abortion group Concerned Women of America has seized upon the deaths of women whose abortions were induced by mifepristone and misoprostol, and petitioned the FDA to take mifepristone off the market. Congressmembers have gotten into the act, too, with Sen. Jim DeMint (R-S.C.), Rep. Roscoe Bartlett (R-MD) and nearly 80 others sponsoring legislation to ban the drug. So far, the FDA has not formally responded to the petition, but it has acted: it changed mifepristone's label to warn women that serious infection could be present even without the typical warning sign of a high fever. After a Centers for Disease Control and Prevention investigation identified a formerly rare species of bacteria known as clostridium sordellii as the infection's cause, the FDA tested batches of the medications. It found no contamination, and the source of the bacteria remains a mystery, at least for now.

Investigations continue, though. Other factors known to be associated with these deaths are geography and anatomy. Four of the six women lived in California at the time of their abortions. They also used misoprostol as a vaginal suppository, instead of taking it by mouth, as done in the original, FDA-approved protocol. Neither factor may have any relevance to the likelihood of sepsis but, as a precaution, some practitioners are switching to oral misoprostol while investigations continue.

In the meantime, what should concerned women and their practitioners do? Women need to be aware of clostridium infection's warning signs; in addition to fever, these include stomach pain, nausea, vomiting, and/or diarrhea. Women who have had a medical abortion and have any of these symptoms should seek immediate medical attention. We must remember, however, that abortion, whether performed medically or by vacuum aspiration, remains a very safe procedure, with extremely low death rates. NWHN will watch the FDA and insist that it be allowed to continue its good work on women's health (on this issue at least); hopefully, we will know more about the mysterious bacteria soon. For more information about abortion procedures, see www.prochoice.org or www.ncap.com.