RU486: Don’t go there

As an American obstetrician-gynaecologist, I have studied the US administrative history and safety record of the abortifacient RU486 for ten years. As a result, I am dismayed that Australia’s parliament may overturn a system where the health minister is made responsible for approving abortion drugs. Before acting, your members of parliament need to know that RU486’s safety is now being heavily scrutinised in the US. RU486 is a dangerous drug which should not be approved in your country.

An RU486 abortion consists of a two-drug regimen. Typically, 200 milligrams of RU486 is taken orally followed, one to two days later, by the vaginal insertion of 800 micrograms of misoprostol. RU486 starves the embryo of blood by blocking placental progesterone receptors; misoprostol induces uterine contractions to expel the dead embryo and other tissue.

Serious dangers can arise if a pregnant woman takes the first pill but fails to take the second, or if she or her clinic miscalculates dates, since the regimen’s dangers substantially increase after 49 days from the date of the last menstrual period. Accurate pregnancy dating requires the use of ultrasound, but ultrasound use is not required in the US.

Since 2001, five North American women (four US, one Canadian) have died from septic shock after taking RU486. In each case the infection was caused by a bacterial species, Clostridium sordellii, an anaerobe found rarely in the vaginal flora. In women of childbearing age lethal infections caused by C. sordellii were rare prior to the Food and Drug Administration’s approval of RU486. Why are these deaths occurring?

Two scientists have independently offered similar analyses. Normally, the body’s innate immune system destroys bacteria before they are able to multiply and secrete toxins into the bloodstream. However, RU486’s potent ability to block receptors for cortisol, a key signalling chemical in the immune system, causes it to malfunction. In some cases septic shock results.

As is the custom of the FDA (Food and Drug Administration), the agency is taking these deaths quite seriously. It updated the RU486 labelling in November 2004 to include “new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex”. In July 2005, after two additional sepsis-related deaths were announced, FDA issued a national public health advisory that highlighted the risks noted previously. The New York Times reported this week that officials from both the FDA and the US Centers for Disease Control and Prevention have decided to work together and convene a scientific meeting in early 2006 to analyse these cases in an effort to protect patients.

Unfortunately, RU486’s dangers do not end there. The FDA has received reports that more than a dozen American women have taken RU486 while having an ectopic pregnancy, where the embryo is located outside the womb. In the US this danger is magnified because the FDA regimen does not require ultrasound documentation of intrauterine pregnancy prior to the drugs’ administration.

When an ectopic pregnancy ruptures, a woman will rapidly bleed to death internally unless she undergoes immediate surgery, and at least one American has died this way. Unfortunately, the signs and symptoms of ectopic pregnancy, like cramping and bleeding, mirror those a woman will experience while undergoing an RU486 abortion. An endangered patient would reasonably expect her symptoms to stem from the RU486 abortion and not from a life-threatening ectopic pregnancy. This danger will be heightened for women who do not have immediate access to surgical services, and this will be particularly so for women in rural areas.

One year ago, the New York Times reported that FDA was aware of 72 cases of blood loss so severe they required transfusions. I have examined over 850 RU486 adverse event reports that were submitted to the FDA. Bear in mind that these reports are filed voluntarily and that the agency receives submissions on only 1-10 per cent of all drug complications. That being said, the amount of blood loss in RU486 abortions gone awry is staggering.

At least 80 women required emergency transfusions, with over half experiencing life-threatening haemorrhages requiring large amounts of blood. Several required the replacement of their entire blood volume. All would have died had they not received timely access to medical and surgical services. Therefore, rapid access to emergency services capable of providing transfusion and surgery is critical for patient survival.

Since 2000, the American medical community is now able to review “real world” RU486 adverse event reports, and the data is alarming. RU486 cannot be administered safely, and Australians will be ill-served by political efforts to hastily approve a drug whose true safety profile is only now being accurately discerned.