Friday, July 22, 2005

Black Box: pharmacologic abortion and infection

The NY Times has an article on the latest two deaths (secondary to septic abortion) in women who've terminated their pregnancies pharmacologically (ru-486 + misoprostol). As a result of the recent reports and the political environment (more likely the The latter) the manufacturer is (at the behest of the FDA) adding a black box warning label regarding infections. [emphasis added]

Five women in the United States have now died after taking abortion pills; four of them most likely suffered lethal bacterial infections, said Dr. Steven Galson, director of the agency's center for drugs.

Still, the risks of death from infection for users of the pill is roughly one in 100,000 uses - similar to the risks of death from infection after surgical abortions or childbirth, Dr. Galson said.


Wendy Wright, senior policy director for Concerned Women of America, a conservative women's group, said news of the latest death proved that label changes would not make the drug safe.

"Changing the label the last time clearly didn't help the latest woman who died," Ms. Wright said. "Sadly, people who support RU-486 apparently believe the risk of death is preferable to having a child."

Those who would prefer criminalization of abortion seem to lay a claim they would prefer women to die from childbirth or pregnancy as they ignore the risks associated with death due to infection post abortion (pharmacologic or surgical) are no greater than those observed post delivery and the risk of death due to complications of pregnancy is almost 12 times higher. [emphasis added]

Analysts from the CDC used data from the Pregnancy Mortality Surveillance System, which includes information on all pregnancy-related deaths reported by state health departments, maternal mortality review committees, media and individual providers. Birth certificates or fetal death certificates yielded additional data for the majority of women who had had a live birth or a stillbirth. The analysts classified a death as pregnancy-related if it occurred during or within one year after a pregnancy and resulted from complications of the pregnancy, events triggered by the pregnancy or the pregnancy's aggravation of an unrelated condition.

A total of 4,200 maternal deaths during the surveillance period were pregnancy-related. The pregnancy-related mortality ratio for the entire period was 11.8 deaths per 100,000 live births; the ratio rose from 10.3 to 13.2 per 100,000 between 1991 and 1999, and the increase was statistically significant. Women younger than 30 had below-average pregnancy-related mortality ratios (8.6-9.6 per 100,000), but the ratio was just above average for those in their early 30s and rose dramatically thereafter (to 21.6 for women in their late 30s and 45.4 for those aged 40 and older). The analysts calculated risk ratios, which confirmed that women aged 30-34 had a modestly higher risk of dying from a pregnancy-related cause than women younger than 20 (1.4), and the risk was markedly elevated among women aged 35-39 (2.5) or older (5.3). Whereas white women had a pregnancy-related mortality ratio of 8.1 deaths per 100,000 live births, the ratio for black women was 30.0 per 100,000; the risk ratio (3.7) suggested that black women were almost four times as likely as white women to die from a pregnancy-related cause.

Of note, two of the women had infections caused by the anaerobic bacteria Clostridium sordellii, the same bacteria cultured in cases of "Toxic Shock Syndrome". The fact that these bacteria are anaerobic should lead away from an assumption of direct causality by ru-486 or pharmacologic abortion and more toward gynecologic source of infection in women with increased vascularization of the endometrial lining of their uterus (such as occurs with thickening of the endometrium that occurs in preparation for implantation), which could lead to bacteremia and subsquent sepsis/septic shock.
In 5-10% of all women, Clostridium species are also found to be normal inhabitants in the microbial flora of the female genital tract. In case of a non-sexually transmitted genital tract infection, Clostridium species are isolated in 4-20%, and clostridium welchii seems to be the most common isolate. Clostridium sordellii is rarely encountered in clinical specimens (1% of Clostridium species), but it has been described as a human pathogen with fatal potential. Two toxins, a lethal and a hemorrhagic (that antigenically and pathophysiologically appear similar to Clostridium difficile toxins B and A, respectively) are responsible for this potential. Reviewing the obstetric literature, only six cases of postpartum endometritis caused by C. sordellii, are described - all being fatal. In addition, one lethal case of spontaneous endometritis resulting from C. sordellii is reported. The clinical aspects of these cases include: - sudden onset with influenza-like symptoms in previously healthy women - progressive refractory hypotension - local and spreading tissue edema - absence of fever Laboratory findings include: - marked leukocytosis - elevated hematocrit. [Acta Obstet Gynecol Scand. 2000 Dec;79(12):1134-5]
Since the risk of prophylactic use of antibiotics exceed the risks of such a rare infection, physicians are being advised to inform their patients to contact them should they experience nausea/vomiting, diarrhea and weakness 24 hours post dosing even if they do not have a fever.

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