FDA reports 2,207 Adverse Events from the 1.52 million women who have taken RU-486

Steven Ertelt of Life News is claiming the following about a FDA report released last April entitled, Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011:

The report indicates 14 women in the United States alone have died from using the mifepristone abortion drug and 2,207 women have been injured by it.[1]

If Steven had said 14 women in the United States alone have died using the mifepristone abortion drug, he would be correct.  However he said, "14 women in the United States alone have died from using the mifepristone abortion drug".  By adding from he implies that the FDA report established a causal link.  Steven may indicate this, but the report itself does not.  Here is what the FDA said in their report.

These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use and other possible medical or surgical treatments.[2]

Steven can say that these events happened from "the mifepristone abortion drug", but the FDA was very clear in the report that they cannot establish this.  I would not necessarily say that Steven is lying, but he is saying the report said something that it did not.

Why can the FDA not say these events were caused by the drug?  They did not run the study.  In a study, you formulate a hypothesis and test it via an experiment.  In a drug study, you need a placebo and a control group among other things.  This document is not a study, it is a report.  The FDA simply compiled a list of adverse events that happened to women who took the drug.  They did not run a study to see if these adverse events were caused by the drug.  As we go through the report I think you will see what I mean.

First let us look at the 14 deaths. Remember this data was collected from September 2000 to April 2011.  An estimated 1.52 million women took mifepristone over this period of almost eleven years. About 0.15% of the women who have taken the drug experience adverse events. These 14 amount to about 0.0009% that died after taking the drug.

"Deaths were associated with sepsis in eight of the 14 reported fatalities "

• "7 cases tested positive for Clostridium sordellii, 
• "1 case tested positive for Clostridium perfringens."

According to the CDC, Clostridium sordellii sepsis is rare and occurs most of the time in patients with underlying conditions.[3]  Women are at their highest risk of infection following the end of pregnancy.

Women are at highest risk of infection from C. sordellii following the end of pregnancy, whether that pregnancy ended in a live birth, induced abortion (medical or surgical), or spontaneous abortion (miscarriage). Fatal infections with C. sordellii and C. perfringens have occurred after medical abortion. In some cases, women can carry the bacteria, but not be infected (known as colonization). The rate of vaginal colonization (when bacteria are present, but not causing an infection) with Clostridium species in the period after abortion has been reported to be as high as 29%, whereas these bacteria have been isolated in the vaginal secretions of 5%-10% of non-pregnant women. Researchers continue to study what percentage of women carries vaginal or rectal C. sordellii and C. perfringens before and after abortion, as well as during pregnancy.

These seven women had just ended their pregnancy through a medical abortion and likely are some of the reported fatal infections. Still, there is no definite causal link.  Perhaps their deaths were from mifepristone.  Perhaps they died simply from an infection attained from ending their pregnancy. Medically it is very hard to prove that seven deaths were a result of a medication.  These seven deaths were spaced out over almost eleven years.  

One woman died of  Clostridium perfringens sepsis.  According to the Louisiana's Department of Health & Hospitals, 

Clostridial sepsis is an uncommon but almost invariably fatal illness following clostridial infection primarily that of the uterus, colon, or biliary tract. This entity must be differentiated from transient clostridial bacteremia, which is much more common. C. perfringens causes the majority of cases of both sepsis and transient bacteremia.[4]

 This fatal infection was probably included in the CDC quote above.  Again, causality has not been proven and it is hard to prove causality with one death over almost eleven years.

The six remaining U.S. deaths involved unique events;

• there was one case each of substance abuse/drug overdose, methadone overdose, 
• suspected homicide, 
• and a delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella), 
• and there were two cases of ruptured ectopic pregnancy.  

This is what I mean about these adverse events happened when they took the drug, not necessarily because they took the drug.  One of these women was most likely not a victim of a suspected homicide, because she took mifepristone.  Some of these events seemingly have nothing to do with mifepristone.