Wednesday, May 02, 2007

RU-486 Is Next


And so it begins...or rather, ends: An amendment to S. 1082, which would suspend FDA approval of RU-486, is being debated on the Senate floor right now.

I just came home and found the announcement in my Inbox (via ACLU). I'm too tired and cranky to watch the debate (assuming it's televised) and post something useful. Maybe later.

UPDATE: From Rachel Perrone (ACLU), a correction:

[I]t appears the amendment was narrower than I originally described. Sen. DeMint has in the past introduced amendments asking for suspension of FDA approval of RU-486, and I was hearing he was going to try it again. His introductory remarks seemed to indicate as much. But instead, he inserted language requiring the FDA to conduct a "risk evaluation and mitigation" study on RU-486. (No doubt laying the groundwork for another go at the drug down the road.) It passed by unanimous consent.

Sen. DeMint's press release is here.

Every single claim in the release is false. Once again, a piece of legislation without any basis in reality has been enacted.



Welcome Pharyngula readers. Here's the condensed version of the facts Sen. DeMint lied about:

-- 6 reported deaths in women using RU-486/misoprostol.

-- 1 case has been determined to be unrelated to abortion/meds, 1 case is still under investigation.

-- 4 cases where, according to the FDA, [w]e do not know whether using Mifeprex or misoprostol caused these deaths.

Of the six fatalities, three involved the rare bacterium Clostridium sordellii. In four cases, women were given part of the drug regimen vaginally, an unapproved method.

Contrast that to reported deaths involving C. sordellii infection unrelated to ETOPs: 8 cases after giving birth, 2 cases following miscarriages, and 1 death linked to infection during the woman's menstrual period.

But wait, there's more!

According to the FDA, the off label regimen used in the cases under discussion was 1 tablet of RU-486 (200 mg) orally, followed by 4 tablets of misoprostol (800 mcg) pv.

[The FDA-approved regimen is 3 tablets of RU-486 (600 mg) orally, followed by 2 tablets of misoprostol (400 mcg) orally.]

All these deaths occurred in patients who used only 1/3 of the FDA-approved RU-486 dose po, but double the misoprostol dose administered pv.



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