FDA, CDC to Meet in 2006 to Discuss Abortion Pill Deaths
BY Randall K. O'Bannon

With results now confirming that four California RU486 patients all died from the same rare, lethal bacteria, officials from the U.S. Food and Drug Administration (FDA) and the federal Centers for Disease Control (CDC) will be meeting early next year to discuss the nature of that risk and explore what, if anything, regulators might do to address the situation, the New York Times reported in a November 23 story.

All told, there have been at least ten deaths associated with use of the abortion pill worldwide, That includes five in the United States since the drug's approval in September 2000.

The first death of a U.S. RU486 patient occurred in Tennessee in September 2001, the result of a ruptured, undiagnosed ectopic pregnancy. The other four deaths all occurred in California between 2003 and 2005 when aborting women contracted lethal Clostridium sordellii bacterial infections.

Researchers from the CDC joined coroners who handled the California cases in publishing an analysis of their findings in the December 1, 2005, edition of the New England Journal of Medicine (NEJM). All four involved young, healthy women who died within a week of their chemically induced abortions, even when, in at least two of the cases, initial physical exams by local emergency rooms showed nothing remarkable. Pathological and microbiological evidence clearly implicated the rare, but lethal, Clostridium sordellii pathogen.

Once testing confirmed the presence of the C. sordellii in the four California deaths, the New York Times said the FDA checked samples of the abortion pill for possible contaminants. None were found, making the cluster of deaths more mysterious.

The Times, citing unnamed officials at the FDA and CDC, said of the planned meeting, "Among other issues, the experts hope to explore whether the abortion pill, called Mifeprex or RU-486, somehow makes patients vulnerable to an infection with Clostridium sordellii, the lethal bacteria. If so, they will explore how such an infection 'could be more easily diagnosed and even prevented,' one official said."

The FDA issued a new public health alert on November 4, 2005, regarding its latest findings. It urged doctors to have patients "contact their health professional if they develop weakness, nausea, vomiting or diarrhea, with or without abdominal pain and fever, more than 24 hours after taking misoprostol." (Misoprostol is the second drug in the two-drug tandem, a prostaglandin used to stimulate powerful uterine contractions to expel the child who has starved to death over the previous couple of days.)

The reason for the concentration of C. sordellii deaths in California is unclear. Perhaps there have been more deaths in other states that have simply not yet been reported to the FDA, or maybe there have just been substantially more RU486 abortions in California than elsewhere. California doesn't publish its abortion statistics, so comparisons are difficult.
Understanding how these women may have been infected and why they died, however, is less of a challenge.

The protocol approved by the FDA in September 2000 specified that women 49 days pregnant or less were to take 600 mg of RU486 orally in the doctor's office, come back two days later, and take 400 mcg of misoprostol orally at the doctor's office. They were then to return to the doctor's office on Day 14 to determine whether the abortion was complete.

Like many other places in the U.S., in California many clinics have followed a different regimen. Some have reduced the dose of RU486, which is expensive; increased the dose of misoprostol; and had women administer the misoprostol to themselves at home, vaginally rather than orally. This saves at least one trip to the doctor's office.

The New York Times said it is "unknown whether it [this revised regimen] may somehow contribute to bacterial infections," but a California state health inspector who looked into the death of Holly Patterson, the first RU486 patient to die in the state, raised several concerns about how the misoprostol was administered.

In a report cited by the Contra Costa Times (2/25/04), the investigator said that in the written material given to the patient, "There was no instruction on hand washing prior to the insertion or that the tablets should be inserted with a bare or gloved finger or if the nails should be short or free of nail polish. These are simple measures to prevent infection."

The problem with infections, as with ruptured ectopic or tubal pregnancies, is that symptoms may be nearly impossible to distinguish from the ordinary side effects of a chemical abortion.

Women who abort using RU486 are told to expect painful cramping and heavy bleeding as the abortion progresses. They are also told that vomiting, diarrhea, nausea, and other gastrointestinal disturbances are common.

These are pretty much the same symptoms of infection that the FDA told doctors to warn patients about in its latest public health advisory.

The problem with Clostridium sordellii is that these infections may not be accompanied by any fever, a usual indicator of most bacterial infections, and something that might help both doctors and patients distinguish the normal abortion process from something else.

In the NEJM report, CDC officials told clinicians to be on the lookout for special symptoms of C. sordellii such as rapid heartbeat, abnormally low blood pressure, swelling of tissues, a concentration of cells and solids in the blood, an increased white blood cell count, and absence of fever. This is all well and good, but some of these symptoms (such as rapid heartbeat and low blood pressure) have also been previously identified as chemical abortion side effects while others require blood work or an examination by a physician to confirm.

If caught soon enough, the FDA suggested that certain antibiotic treatments may help (Public Health Advisory, 7/19/05). But by the time the woman (or her doctor) realizes her symptoms are not simply side effects of the abortion process and seeks medical attention, the bacteria may have already begun to overwhelm her system.

There also may be factors involved in the chemical abortion process itself that contribute to the likelihood of infection. A pharmacology professor from Brown University, Ralph P. Miech, argued in the July 2005 issue of the Journal of Pharmacotherapy that RU486 acts to chemically suppress the immune system. This, coupled with the prolonged bleeding that is typical of chemical abortions, may make women more susceptible to bacterial infections like Clostridium sordellii.

Three of the victims' families have filed suit against Danco, the U.S. distributor of the pill, claiming they were not given adequate warning about the dangers of the drug, and at least one relative and several legislators have asked for RU486 be pulled from the market. It is not clear whether that option is under consideration.

An editorial appearing in the same issue of the NEJM tries to argue that these deaths are tragic but rare and not clearly related to the method itself. It recommends that patients be informed of this risk before initiating the abortion and that they should be vigilant for symptoms afterward, but says regulators should "keep this rare complication in perspective and not overreact to scant data by prematurely foreclosing the only approved medical option for pregnancy termination."

In theory, the FDA could pull the drug, somehow restrict its distribution, add new warnings to the label, or simply declare the deaths to be unexplained coincidences unrelated to the drug or the method and leave things as they are.