Study Details Deaths of Women who Took RU-486
ROBERT SIEGEL, host:
In this week's New England Journal of Medicine, researchers report details of the deaths of four young women who took the abortion pill RU-486. All of them were in California, and all died of massive bacterial infections. NPR's Patricia Neighmond reports.
PATRICIA NEIGHMOND reporting:
Five years ago the Food and Drug Administration approved the oral drug RU-486 to induce abortions. In the US, the drug is given together with a second drug that is inserted vaginally. The drug combination is taken at about seven to weight weeks' gestation. RU-486 prevents the uterus from forming the lining needed to maintain pregnancy; the second drug causes contractions.
Researchers from the Centers for Disease Control and Prevention report that all four women died within one week of taking the drug combination. They died from an unexpected bacterial infection of the blood. CDC epidemiologist Marc Fischer says the bacteria produced a virulent toxin.
Dr. MARC FISCHER (Centers for Disease Control and Prevention): The toxin causes a leakiness from the capillaries, so fluid from the blood vessels leaks out into other tissues. Your heart rate increases, and eventually your blood pressure drops. And your body can't keep up with the loss of the fluid, and that's eventually what causes the patient to die.
NEIGHMOND: In these cases symptoms escalated quickly, and the women died within 24 hours of being admitted to the hospital. Dr. Michael Greene directs obstetrics at Massachusetts General Hospital. Greene says symptoms of the infection are similar to what's expected from a medical abortion, and that, he says, is part of the problem.
Dr. MICHAEL GREENE (Massachusetts General Hospital): It's very difficult to know when the normal cramping pain, bleeding, nausea, vomiting that is commonly associated with this procedure crosses over from the normal and the expected to the abnormal and the unexpected.
NEIGHMOND: Nonetheless, Greene says, a fatal bacterial infection like this remains very, very rare. Its risk to the woman are similar to that of a surgical abortion. At the same time, researchers say, there's no proof that either drug caused the deadly infections, but there are a number of questions. For example: Why were all four deaths among women who lived in California? Researchers have already concluded the drugs were not tainted, nor taken in a way other than prescribed. But there is concern that inserting the second drug vaginally may create an environment favorable for infection. Epidemiologist Fischer.
Dr. FISCHER: And the last and, you know, maybe one of the most likely reasons is just that because these cases have been reported over time, because the first one occurred back in, you know, September of 2003, it got a lot more attention locally. And maybe physicians and patients in California are just more aware of this, and so far that's where the cases have been reported from.
NEIGHMOND: Early next year federal and state health officials will meet to discuss the risks of RU-486. In the meantime, a number of anti-abortion groups have rallied to get the drug taken off the market. Wendy Wright with Concerned Women for America.
Ms. WENDY WRIGHT (Concerned Women for America): RU-486 has turned out to be even more deadly than we had expected, and the FDA needs to rescind its approval of this drug. In any other case, the pharmaceutical company would be responsible and would pull the drug themselves. But with RU-486 the drug distributor has only one product. Danco does not have an incentive to pull the drug from the market.
NEIGHMOND: Danco Labs has sent letters to doctors and health-care providers warning about the risks of infection associated with the abortion pill. And the Food and Drug Administration has added that risk to the drug's warning label. Patricia Neighmond, NPR News.
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