RU-486 and Death: Two more women have died after using the abortion pill, RU-486. Last fall, it became clear that four out of the five deaths at that time were caused by a widespread infection by a type of bacteria that resides in the vagina. It also became clear at that time that a lot of abortion providers were using the second pill involved in medical abortions - misoprostol -not in the recommended oral form, but as vaginal suppository instead. The FDA reminded them that the vaginal route was not safe:
Last fall, the FDA reminded doctors that vaginal use of the second drug, called misoprostol, is not what the agency formally approved. The drug is supposed to be taken orally. On Friday, the agency repeated that directive.
"We felt it was urgent to reiterate yet again what is the only approved method for safe administration of RU-486: oral administration followed carefully by their physicians with follow-up on day 14" to make sure the abortion is complete, said the spokeswoman.
Evidently, Planned Parenthood didn't get the message:
Vanessa Cullins, M.D., Vice President for Medical Affairs for the Planned Parenthood Federation of America, said there was good reason for the vaginal use that its clinics had been recommending.
"The vaginal route has less side effects and also enables women to have medical abortions up to 63 days, as opposed to the 49 days that the oral route is approved for," she said.
Introduction of a deadly vaginal bacteria into the blood stream is a rather major side effect. It isn't clear if the two women who died recently recieved the misoprostol as a vaginal suppository or if they received it at Planned Parenthood, but you would think the reports last fall would have been enough to make Planned Parenthood change their policy. They've changed it now, though. You don't have to tell them a third time.
"The FDA reminded them that the vaginal route was not safe..."
Actually, the FDA reminded them that the drug had not been approved for vaginal administration. That's not the same as being proven unsafe. As a doctor, you know that drugs are routinely used in ways that the FDA hasn't approved.
Death from surgical abortion is extremely rare. Here are the most recent statistics I could find, from the CDC:
In 1998 and 1999 (the most recent years for which data are available), 14 women died as a result of complications from known legal induced abortion. Ten of these deaths occurred in 1998 and four occurred in 1999; no deaths were associated with known illegal abortion.
In 1998 there were 884,273 abortions. In 1999 there were 861,789.
RU-486 was approved in 2000. Since then, the distributor estimates that 460,000 women have used it. Six deaths in 460,000 users vs. 14 in 884,273 and 10 in 861,789. In all cases the incidence is very small, so they are probably about as safe.
Point taken about the difference between "safe" and "recommended." However, after the New England Journal of Medicine reported the sepsis from vaginal bacteria in the four women last fall, it really should have been apparent that suppositories probably weren't the best route.
I make of that article that it was published in 1988, in France, well before the link between sepsis from vaginal bacteria and the use of vaginal suppositories was discovered last year with its use in the states. I'm not knowledgeable enough about the French system for drug approval, but the Europeans do seem to OK more drugs than we do here in the States, which makes me think they aren't as vigilant about side effects before approving them. (The article also involves a different drug used as the suppository than misoprostol, the one used in the U.S.)
The point is, that last year, it became obvious that the deaths from RU-486 were due to sepsis from bacteria found in the vagina and that all of the dead women/girls had used the vaginal suppository form rather than the oral form. At that time, it became obvious that providers should think twice before using the suppository form. But, sadly, it took two more deaths for the abortion clinics to change their policies.