The FDA says it is investigating two more US deaths associated with the medical abortion drug Mifeprex (mifepristone) that were recently reported to the agency by the manufacturer, Danco Laboratories. The FDA has only received verbal notification about the deaths, it says, adding that “we are investigating all circumstances associated with these cases and are not able to confirm the causes of death.”
Last year, an FDA alert confirmed four previous deaths from sepsis that occurred between 2003 and 2005. All four cases tested positive for Clostridium sordellii and involved an off-label dosing regimen.
Concerned Women for America is calling on the FDA to pull Mifeprex from the market, saying it “has pulled other drugs that have caused fewer deaths and less severe complications. ... Why the double standard for an abortion drug that is now linked to the deaths of seven healthy women and over 800 other reported complications?”
The conservative advocacy group said the FDA pulled the imaging agent NeutroSpec after it was linked to two deaths, 20 severe reactions and 46 other less severe reactions.