Ohio Drug Litigation Lawyers

FDA Investigate Four Death Septic Shocks, Due To Use Of Abortifacient Mifeprex

The Food and Drug Administration’s investigation of the deaths of four American women who died from septic shock

On or about July 19, 2005, members of Congress became aware that four American women had died after taking RU-486.   FDA and the Centers for Disease Control justifiably investigated these fatalities, and a summary of the results was published recently in the New England Journal of Medicine.   I am encouraged by the joint FDA-CDC effort to examine the serious health and public safety risks posed by RU-486.  The available data strongly suggest that we have much more to learn.  Consequently, I was pleased to learn that FDA intends to hold scientific meetings next year to examine these infection-related deaths.   

As FDA and CDC confirmed, each of the four women who died from septic shock were infected by Clostridium sordellii, a potent anaerobic bacteria.  It is also known that a Canadian woman died from septic shock linked to C. sordellii after taking RU-486.   These women did not possess other risk factors or underlying medical conditions that would have predisposed them to sepsis.  In general, they were young and healthy.  Moreover, although these women complained of weakness, nausea and vomiting, these symptoms are consistent with the medical abortion procedure, and they had no fever to indicate an infection.  Nevertheless, each woman died soon after being hospitalized. 

I am deeply concerned about the safety of the RU-486 regimen and the possibility that there may be some deaths and many non-fatal adverse events that have gone unreported.  An  article accompanying the New England Journal of Medicine Report, referenced above, notes that RU-486 abortions present patients with a ten times greater risk of death than surgical abortions done early in a pregnancy.   The New England Journal of Medicine Report investigating the sudden post-RU-486 deaths of healthy young women states the obvious: “These cases indicate the need for physician awareness of this syndrome and for further study of its association with medical abortion.”  

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