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News of the Day ... In Perspective

12/04/2005

RU-486 could be ten times riskier than surgical abortion

Four deaths from endometritis and toxic shock syndrome occurring one week after abortions induced by RU-486 (Mifeprex) were reported in the Dec 1 issue of the New England Journal of Medicine (Fischer M et al. N Engl J Med 2005;353:2352-2360).

In a Nov 30 interview with the San Jose Mercury-News, accessible through the Journal, lead author Marc Fischer of the CDC stated that the risk of maternal death from RU-486, about one in 100,000, is the same as for other types of abortion. The risk of death from surgical abortion in the first trimester, the time period in which RU-486 is prescribed, is about one in a million.

“On the surface of it, it seems like one risk is 10 times higher than the other one. However, when you get numbers that are that small, they are difficult to measure with precision, and I don’t think I or anyone else, on the basis of available data, at the moment would be willing to say that this is a necessarily significant difference.”

The four cases are based on reports to the FDA; it is believed that adverse drug effects are seriously under-reported. The death of 18-year-old Holly Patterson would not have been reported if her father had not pursued the issue aggressively.

As the Australian parliament is about to vote on approving RU-486, three Catholic Respect Life groups issued a statement saying that “[t]he U.S. FDA approved RU-486 in 2000 under pressure from Congress and the Clinton Administration. This occurred despite warnings from researchers that adequate clinical trials had not taken place, that RU-486 did not fit the category of ‘accelerated approval regulations,’ which were only meant to be used for life-threatening diseases like AIDS and cancer.”

The FDA will investigate whether the abortion pill somehow makes patients susceptible to the lethal bacterium, Clostridium sordellii (NY Times 11/23/05).

Sen. Jim DeMint (R-SC) has told the Baltimore Sun that RU-486 could be pulled from the market.

Senators Brownback (R-KS) and Coburn (R-OK) pointed out in a letter to their colleagues that a number of Mifeprex users are between the ages of 12 and 17 and do not need to have their parents’ permission. The FDA waived the requirement to test the drug in this age group. (See: PRI Weekly Briefing 12/2/05, www.pop.org).

Additional information:

“Hospital failed to cite Holly Patterson’s death from RU-486 as unusual”

Maternal health risks in abortion, see AAPS amicus in Ayotte v. Planned Parenthood

AAPS comments on OTC status for “morning after pill”

 

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