FDA Health Advisory Issued for RU-486 (Mifepristone)

By Erik Ricasa

Published on July 23, 2005

All four women suffered sepsis, or bacterial infection, following the administration of unorthodox levels of the drug combination. Women received 200 mg of Mifeprex, followed by 800 mcg of misoprostol. This differs greatly from the approved regimen of 600 mg Mifeprex and 400 mcg misoprostol.

The sepsis-causing bacterium in two of the cases has been identified as Clostridium sordellii, although the patients in question did not display classic signs of bacterial infection. The bacterial origin of sepsis in the other two women has not yet been determined and is currently under investigation by the FDA, the Centers for Disease Control and Prevention, and other government officials.

In addition to the investigation of these deaths, the FDA is also working with the manufacturers of RU-486 to determine whether either component of the drug combination was contaminated with Clostridium sordellii.

Until more information is released, the FDA recommends that medical providers keep a close watch on patients who are undergoing medical abortion; signs of sepsis may include nausea, vomiting, diarrhea, and weakness, though fever or other signs of infection may be absent.

Any sign of infection in these patients should be treated immediately with antibiotics that are effective on anerobic bacteria, including Clostridium sordellii

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