Take one, Bill. I'm curious as to how it'd effect you.

The first drug is a synthetic steroid that inhibits both progesterone (causing the abortifacient effect) and glucocorticoids (a type of steroid hormone). Not having much progesterone in my body (certainly not relative to a pregnant woman), if I took a little, probably nothing would happen. If I took more, my sex drive and sense of well being would drop, as it's a precursor to other sex hormones, as well as throwing inversely related hormones out of wack. If I took enough, it'd give me symptoms of Addison's Disease (due to the anti-glucocorticoid effect) - fatigue, weight loss, muscle weakness, irritability, numbness, salt cravings, hypoglycemia, low blood pressure. All these problems would go away after I was finished taking the drug.

The second drug (Misoprostol) probably wouldn't do much except stimulate the secretion of mucous that covers my intestinal tract, thus insulating it from gastric ulceration (another indication for the drug). Not having a uterus, it wouldn't stimulate any uterine contractions. Might give some side effects at the RU-486 dose, like nausea, vomiting, diarrhea, etc.

I'd have little reason to take either, but I certainly wouldn't be afraid to. The first drug is hella safe, as most hormone inhibitors are in acute doses. The second drug is a little more interesting (IMO), but deaths and troubling side effects may simply be related to infection caused by topical application rather than oral dosing.

Bill, the dosage of the mifeprisone may be an issue in the off-label regimens associated with deaths from a specific type of infection.

I am certainly not going to be accused of pumping up the risk of the procedure to promote an anti-aborton agenda, but I think there is some suggestion that revised regimens may increase the risks of a rare kind of sepsis, particularly dangerous because it may escalate without tell-tale signs, such a fever.

One thing about this story has been how inaccurate media reports have been.

A Gyno's medblog, The Well-Timed Period, has been covering the issues with some detail, so I'll just quote from her.

The off-label regimen used was 1 tablet of RU-486 (Mifeprex), or 200 mg, orally, followed by 4 tablets of misoprostol, or 800 mcg, PV.

One more time: The FDA-approved regimen is 600 mg of RU-486 (Mifeprex) orally, followed by 400 mcg of misoprostol orally. The off-label regimen used was 200 mg of RU-486 (Mifeprex) orally, followed by 800 mcg of misoprostol PV.

All three articles correctly report that the off-label regimen involved a different route of administration for one of the drugs, misoprostol (PV vs. orally). What none of the articles mention is that the off-label regimen involved significantly different doses of both drugs. In fact, they all mistakenly report that, for both drugs, the approved dosage was used.

See her posts here, and here

SarahW -

Bill, the dosage of the mifeprisone may be an issue in the off-label regimens associated with deaths from a specific type of infection.

I doubt it's the Mifepristone, rather the second drug in the protocol - misoprostol. As you excerpt:

The off-label regimen used was 1 tablet of RU-486 (Mifeprex), or 200 mg, orally, followed by 4 tablets of misoprostol, or 800 mcg, PV.
One more time: The FDA-approved regimen is 600 mg of RU-486 (Mifeprex) orally, followed by 400 mcg of misoprostol orally. The off-label regimen used was 200 mg of RU-486 (Mifeprex) orally, followed by 800 mcg of misoprostol PV.

I doubt taking LESS Mifeprex is the key factor in sepsis, though I can't claim expertise. It is odd that the off-label was less of the first and vastly more of the second.

BUT conceptually - rubbing a substances that causes irritation directly on the mucosal membrane of the vagina vs. simply taking an oral dose of the same drug - a drug that's safely taken for other indications - is vastly more likely to lead to an infection than the dosage combinations, IMO. A simple lack of hygiene while applying it could cause a sneaky infection.

Though I grant that the influence of the dosages themselves are not out of the realm of possibility.

Bill, there are at least some reasons why an inadequate dose of mifipristone might contribute to sepsis; including the additional culture medium of blood and tissue in the uterus.

The organism implicated Clostridium sordellii is found in the genital tracts of healthy women, and deaths from this organism occur after spontaneous abortion, natural delivery and C-sections, and surgical abortion as well.

including the additional culture medium of blood and tissue in the uterus.

that's a very good point.

UPDATED: I have to think about this. What is the mechanism for "additional culture medium of blood and tissue in the uterus?" Insufficient blockage of progesterone which leads to ... "the additional culture medium?" This drug is administered in a single dose, acutely, which might limit this angle a bit. Still, good point, even though I'm probably missing the mechanism.

Again, I'm operating out of my depth here, esp in the gyno department.

Not having a uterus, it wouldn't stimulate any uterine contractions.

What about your mangina?

it's probably like the Titanic, more than one thing has to go wrong.

As I said, C. Sordelli is a common vaginal bacteria. Anti-progestins cause changes in the cervix that may allow the organism to more readily colonize the Os/cervical canal. This canal is a low oxygen environment - C. sordelli thrives in anaerobic conditions and derives nutrition from degenerating/decaying tissue (including the fetal tissues and endometrium). As when a (spontaneous) abortion is threatened for a long time before expulsion of the products of conception, or when a (spontaneous) abortion is incomplete, the more time the process takes to expell the bacteria's source of nutrition, the greater the chance of infection. (The process of spontaneous abortion is very similar to the effects of mifepristone with regards to the lack of progesterone supporting the pregnancy.)

But wait - there's more..systemic antiglucocorticoid actions are a know hormonal effect of antiprogestins.

Some (reputable) guy whose name I forget (I'm not so reputable, but I'll try to find it) has recently proposed that antiglucocorticoid effects may interfere with cytokines, and impair immune response in susceptible individuals. This could have two deadly effects -the body's ability to fight off C. sordellii is impaired, yet the typical warning signs and symtoms of a nasty infection are not present.
It gets out of control, and toxic by-products of the bacteria induce widespread septic shock.

Or not. But the reason surgical abortion may have one up on a slow medical abortion is that while instrumentation always runs the risk of introducing infection, there less nutrition for the bacteria to thrive on when all the tissue is curetted away, and there would be no suppression of immune response and less chance for the bacteria to cause septic shock....however, this kind of infection CAN follow any surgical abortion and indeed, any pregnancy.

Nice summary. And here I thought all you knew how to do was wisecrack and p-shop. In that respect, this puts you at least one item ahead of dorkafork.

As when a (spontaneous) abortion is threatened for a long time before expulsion of the products of conception, or when a (spontaneous) abortion is incomplete, the more time the process takes to expell the bacteria's source of nutrition, the greater the chance of infection.

Well this is what I was suspecting, though I doubted the angle because the abortion largely either happens or it doesn't over a very short, finite and consistent window of time (a day or so), thus the difference in protein wouldn't be that appreciable, and the misoprostol is what determines whether the protein and bacteria fuel is expelled. But I guess a lot can happen in 24-48 hours, and I'm certainly still out of my depth with such wild guesses.

(Point deleted)
(That was totally wrong. I got caught up thinking of the anti-glucocorticoid action in the second drug for some reason, rather than it being the secondary effect of the first drug. Oops.)

So yeah ...

it's probably like the Titanic, more than one thing has to go wrong.

... very well could be. Though it could also be monofactorial. I don't know. Shrug. Let the FDA figure it out. Nice points.

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