Deaths Following Medical Abortion: April 10, 2006 Update
It is remarkable how quickly pharmaceutical products can move through the regulatory approval process, so much so that one might question the effectiveness of research and development by manufacturers. Since the approval of mifepristone (marketed as Mifiprex) in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of six deaths in the United States following medical abortion with mifepristone and misoprostol. Of the two most recent deaths reported to FDA in March 2006 (see DC Metro Area Medical Malpractice Law Blog, Deaths Following Administration of Medical Abortion), one has been determined to be unrelated to an abortion or to the use of these medications, while the other, with symptoms of infection, continues to be under investigation. According to previous FDA reports, four women in the United States have died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. All four women were infected by the same type of bacteria. While sepsis is a known risk of abortion in general, the symptoms in these four cases were not typical of sepsis. FDA has tested batches of mifepristone and misoprostol and has not found any contamination with the type of bacteria involved in the four cases. FDA recommends that women who have taken these medications for medical abortion contact a healthcare professional immediately if they develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol.