RU-486 and Clostridium Sordellii

The controversial RU-486 (named for the French pharmaceutical firm that created it-Roussel-UCLAF) has made headlines because of the five (four American, one Canadian) deaths that have occurred due its usage. The deaths were linked to a rare bacterium called Clostridium sordellii that seems to be more likely found in pregnant women than the general population.

RU-486 is a combination of two drugs given to create a medical (as opposed to surgical) abortion in early pregnancy. The FDA approved regimen of RU-486 for early pregnancy termination is identical to that in European countries where the drug has been used for nearly two decades. Abortion patients take three oral doses of 200-milligram tablets of mifepristone on the first and second day of the regimen followed by 200-micrograms orally of misoprostol on day three. These doses should be taken in a doctor’s office and the patient should return on day 14 to have a checkup.

Medical abortion is chosen over surgical abortion for many reasons, the most common being that a medical abortion can be implemented earlier than a surgical abortion. Most are done before or around seven weeks of gestation and are not recommended past nine weeks of gestation. Another reason that many women choose medical abortion is because of privacy. Many American doctors allow women to take the pills at home. This is not, of course, what the FDA has approved for the Ru-486 regimen. In order to give abortion patients a lower dose of the mifepristone doctors allow abortion patients to insert the misoprostol vaginally in the privacy of their own homes.

Clostridium sordellii is an anaerobic bacterium that grows in environments without oxygen. This makes the vagina a perfect environment for the growth of Clostridium sordellii. Most commonly Clostridium sordellii is found in soil but about 10 percent of women harbor the bacteria in their intestinal and genital tracts. Usually it causes no symptoms. The problem with diagnosing Clostridium sordellii in women who have symptoms is that it does not cause fever, which is an indication of infection in the body. The bacterium does cause abdominal pain and nausea, but both are common in a medical abortion. Most all of the fatal cases of Clostridium sordellii have been due to infections of the uterus or perineum following childbirth.

Scientists cannot seem to agree on whether or not the mifepristone actually facilitates the death that is caused by Clostridium sordellii. In the September 2005 issue of the Annals of Pharmacology, a study done by Ralph P. Miech MD, PhD of Brown University Medical School shows:

“Theoretically, it appears that the mechanisms of mifepristone action favor the development of infection that leads to septic shock and intensifies the actions of multiple inflammatory cytokines, resulting in fulminant, lethal septic shock.”

Danco, the company that makes Mifeprex responded to Miech’s claims adamantly saying that “there is no medical evidence to suggest that the Mifeprex regimen – a combination of mifepristone followed by misoprostol – presents an increased risk of infection or death and no causal relationship has been established.”

In May of 2006, scientists from public health agencies in the United States met to discuss the role of RU-486 in relation to those who died from a Clostridium sordellii infection after having a medical abortion. Top scientists from the FDA, the CDCP, and the National Institute of Allergies and Infectious Diseases discussed the fact that the drug misoprostol, used in the chemical abortion regimen to stimulate the uterine contractions that expel the embryo, was the cause of a weakened immune system and possibly rendered some women who harbor Clostridium sordellii unable to fight off the infection, thus leading to death. Another research study showed that mifepristone interrupts the brain’s stress hormones that regulate the immune systems. Painkillers such as codeine (commonly given for pain management in medical abortions) might prolong mifepristone’s presence in the body.

After the meeting and discussion about RU-486 and Clostridium sordellii scientists definitely see a link between the two and deaths but still have no conclusive evidence that would cause RU-486 to be banned in the United States. All of the scientists agree that more research is needed.

The FDA has strict rules about the use of RU-486 (the drug should be taken only orally and not vaginally) and the National Abortion Federation is adamant that medical care providers follow the correct protocol in administering the drug or they will risk loosing their medical malpractice insurance. In the United States, some abortion doctors have decided against the use of medical abortion altogether, instead favoring the use of surgical abortions which tend to be less painful and are ten times less likely to cause death than medical abortions. Until March of 2006, despite the FDA’s strict warnings and guidelines, Planned Parenthood continued to administer misprostol vaginally. After yet another (however, still under investigation) death in March, Planned Parenthood began asking patients to take the misoprostol orally.

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