Mifeprex (RU486) is the abortion pill that has been shrouded in controversy since 1996 when the federal advisory committee that recommended its approval was forced to meet under the protection of federal marshals. Clostridium sordellii is a rare and lethal bacterium for which there is no known cure once an infection takes hold.
No one had ever suggested or suspected that the two might be linked in some way. That is until now.
With the confirmation that at least five women have died from Clostridium sordellii infections within days of taking the drug, medical experts are now faced with far more than a coincidence and a public safety issue that must be satisfactorily explained by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
Since four of the five deaths occurred in a cluster between September 2003 and May 2005 in California there was speculation that contamination may have played a role in the fatal infections. Testing by the FDA, however, proved negative for any such contamination.
As a result, the decision has been made to convene a special meeting early in 2006 at which officials from the FDA and CDC will examine what has become a perplexing medical mystery. No doubt, the fifth death, which occurred in Canada during clinical testing of the drug in 2001, will now be reexamined.
In each of the deaths, Clostridium sordellii infected the woman’s uterus, flourished and then entered their bloodstreams. Death occurred in each case within one week of taking the drug.
This deadly bacterium can cause nausea, vomiting, diarrhea, and weakness. Since fever may not occur, however, victims often succumb to toxic shock without ever realizing how sick they really were. Once the infection has flourished, antibiotics are often ineffective because even in death, the bacteria continue to release deadly toxins.
Many experts are concerned about these revelations for a number of reasons. One is that other similar deaths may be going unreported because the association between the drug and the infection has not been made. Another is the well known fact that in the case of any problematic drug, a significant number of adverse reactions are simply not reported to the FDA or the manufacturer.
A third is that some researchers believe the drug itself impairs the immune system and makes patients more vulnerable to infection with Clostridium sordellii. Dr. James McGregor, of the University of Southern California, discussed that theory earlier this year in two medical publications.
As a result, critics of the drug are calling for its removal from the market pending the outcome of the combined FDA and CDC probe.
Warnings about the drug’s possible link with Clostridium sordellii were placed on Mifeprex’s label in July, and the FDA updated this information on its Web site on November 4, without announcement, after it discovered that all four CalifornCalifornia deaths involved the Clostridium sordellii bacterium.