Deaths Following Medical Abortion: AP, AFP, and Reuters Get The Story Wrong

Reporting on deaths in women who underwent medical abortions, three major news organizations--AP, AFP, and Reuters--get the central, and most basic, facts wrong.

Here's a bit of background. One of the early medical termination regimens involves taking two drugs--mifepristone (RU-486, Mifeprex) and misoprostol. According to its manufacturer, ~ 560,000 women have taken RU-486 since its approval in September 2000. A total of 7 deaths have been reported in women using these two drugs. [AP reports one was a ruptured ectopic, but I haven't been able to verify that.] Of these, 4 were caused by sepsis (generalized infection), and the cause of death for the most recent 2 isn't known yet. All these deaths, and this is the key piece of information, occurred in women who used the drugs in an off-label manner.

Moving on, let's look at what the major news organizations are telling you.

First, from the AP article:

In a cluster of four cases in California, the women died from an infection of the bloodstream, or sepsis. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later.

Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, a so-called "off-label" use of the drug....

If you even manage to catch the fact that two different drugs are mentioned--the "abortion pill" (RU-486, mifepristone), and the another drug (misoprostol)--the article tells you that the FDA-approved regimen is swallowing (oral) three tablets of RU-486, followed by oral administration of two misoprostol tablets two days later. That is correct. However, what follows isn't. Namely, that the four women who died used an off-label regimen consisting of swallowing three RU-486 tablets, followed by intravaginal (PV) administration of two misoprostol tablets.

Second, the AFP article:

The FDA said that four women had died from bacterial infections 2003-2005 after so-called off-label use of the misoprostol, inserted vaginally, rather than orally, as indicated. The mifeprex drug in the regime was given orally, as directed.

The good news is that AFP makes it clear we are discussing a two-drug regimen. The bad news is that the information about what regimen was used--three RU-486 (mifeprex) tablets given orally, followed by two misoprostol tablets PV--is incorrect.

Finally, from Reuters:

Officials cautioned against unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.

"The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency said.

Again, the regimen information is reported incorrectly. [Bonus points if you can spot the problem. Hint: read the FDA quote carefully.]

Now, it's clear that all the articles are based on this FDA press release.

This is what the FDA release says is the approved two-drug regimen for early medical termination:

The approved Mifeprex regimen for a medical abortion through 49 days' pregnancy is:

Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once

Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.

So, the FDA-approved regimen is 3 tablets of RU-486 (Mifeprex), or 600 mg, orally, followed by 2 tablets of misoprostol, or 400 mcg, orally.

The AP article reported this one correctly; the other articles didn't go into details.

Continuing, from the *same* release, this is what the FDA says was the [off-label] regimen used in all four cases of fatal infection:

All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol.

So, 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.

If you think drug dosage is not essential information, go ahead and take an entire bottle of aspirin for a headache, or take antibiotics for only one day of a seven day course and see what happens. [WARNING! This was a (possibly bad) joke, not an actual suggestion. Don't exceed the recommended daily dose of aspirin, and always finish a full course of antibiotics. And, yes, I do know I'm belaboring the point.]

When it comes to reports of deaths in women using RU-486 and misoprostol for medical abortions, what we should be discussing is if either one of these drugs, or both, could be a contributing factor. [So far there is no evidence for that.] But you tell me how we can be informed discussants when AP, AFP, and Reuters can't even get simple information, like dosage regimens, right. Nothing more than reading comprehension was involved in reporting this correctly. The information is clearly spelled out in the FDA press release. How can we expect accurate reporting of truly complex issues (how do we determine if the drugs are involved? What would a hypothetical mechanism of action be?) when the basics are misreported?