A Brief look at Mifepristone 2004 & 2011

In 2004 the FDA updated it's warning label to mention that women had died of rare fatal infections after taking mifepristone.  Though no causal relationship could be established for the two women who had died from sepsis, the FDA thought that patients and doctors should be warned.[FDA]


In 2004 360,000 women had taken mifepristone since it came on the market in 2000. There were some adverse events.[1]

• The F.D.A. has received 676 reports of problems with the drug, including
• 3 Deaths  
• 2 deaths from sepsis 
• 1 death from a ruptured ectopic pregnancy
• 17 ectopic pregnancies 
• 72 cases of blood loss so severe that they required transfusions 
• 7 cases of serious infections

Again there were no causal relationships.  Now let us fast forward to the April 2011 FDA report.  Since September 2000 there were a total of[2]

• About 1,520,000 women had taken mifepristone
• 2207 Adverse Events including
• 14 Deaths
• 8 deaths from sepsis
• 2 deaths from ruptured ectopic pregnancy
• 1 case each of substance abuse/drug overdose, methadone overdose, 
• 1 suspected homicide, 
• 1 delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella)
• 58 ectopic pregnancies
• 339 cases of blood loss so severe that they required transfusions
• 256 Infections
• 48 cases of serious infections

In the last six years,

• The number of women who have taken mifepristone has quadrupled 360,000::1,520,000
• The Adverse Events have tripled 676::2207
• The deaths from sepsis have quadrupled 2::8
• The deaths from ectopic pregnancy double 1::2
• Ectopic Pregnancies increased 341% 17::58
• The cases of blood loss requiring a transfusion increased by 470% 72::339
• The serious infections increased by 685% 7::48

About 0.15% of the women who have taken the drug experience adverse events.  Remember this is all cumulative.