Mifeprex warnings updated in wake of four deaths: sepsis identified as cause of death.(News)

The maker of the abortion drug mifepristone has again announced it is adding to the warnings section of the product's package insert--less than a year after a previous revision--to include information on four deaths that have occurred in women using the drug.

The previous revision warned that cases of sepsis associated with mifepristone use have been reported. Sepsis was the cause of death in all four cases that prompted the latest revision, according to a public health advisory issued by the Food and Drug Administration last month.

In two of the cases, the organism involved was Clostridium sordellii, known to colonize the intestinal tract and rectal area, but rarely to cause infection, although it can cause surgical and postpartum infections and has caused infections in patients receiving tissue transplants.

The same organism was involved in a fifth death that occurred in Canada during a clinical trial of mifepristone (Mifeprex) conducted in 2001.

The organism involved in the other two fatal cases that have occurred in the United States since the approval of the drug has not been identified.

All four fatal cases in the United States have occurred in California--two in 2003, one in 2004, and one in 2005.

The two important features common to all the deaths, which are noted in the new warnings, are that the women used the regimen of mifepristone followed by vaginal misoprostol, rather than the FDA-approved regimen of mifepristone followed by oral misoprostol. In addition, the women did not have the typical clinical appearance of sepsis when they presented for medical attention in that they did not have fevers.