RU-486 did not cause woman's death

The FDA announces that one of two recent deaths originally thought to be related to Mifeprex was not caused by the drug.


Sarah Goldstein
April 12, 2006 2:26AM (UTC)

The Kaiser Network reports that on Monday the Food and Drug Administration announced that the drug Mifeprex, known generically as mifepristone or RU-486, which, when taken with misoprostol can cause a nonsurgical abortion, was not, as originally thought, responsible for one of the two recent deaths of women who had taken the drug. Their deaths last month raised red flags when they appeared to have symptoms similar to the four California women who died from toxic shock infection caused by Clostridium sordellii, a rare and deadly bacterium. Additionally, all of the Californians who died after taking the drug were given misoprostol vaginally, rather than orally, which doctors are no longer recommending.

In response to the findings, the FDA issued a statement yesterday saying that "of the two most recent deaths one has been determined to be unrelated to an abortion or to the use of Mifeprex and misoprostol, and the other, with symptoms of infection, continues to be under investigation."

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Broadsheet will continue to follow this issue, which can be extremely confusing and potentially frightening. It is important to note that even with the four RU-486-related deaths and one still under investigation, since FDA approval of the drug in 2000, it has been used by somewhere between 460,000 and 575,000 women in this country and 500,000 more internationally. The drug remains under rigorous testing and review; on May 11 the FDA will convene a scientific conference "over the safety of the drug regimen to terminate early pregnancy."


Sarah Goldstein

Sarah Goldstein is an editorial fellow at Salon.

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