January 31st, 2011 by Helen Scholz
Mifeprex (mifepristone) Information
Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy (within 49 days of the start of a woman’s last menstrual period). Since its approval in September 2000, the Food and Drug Administration has received reports of serious adverse events, including several deaths, in the United States following medical abortion with mifepristone and misoprostol. Each time FDA receives a report of a serious adverse event or death after medical abortion with these drugs, the agency carefully analyzes the available scientific information to determine whether or not the serious adverse event or death is related to the use of the drugs.
As previously reported by the agency, several of the women who died in the United States died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. Sepsis is a known risk related to any type of abortion. Most of these women were infected with the same type of bacteria, known as Clostridium sordellii. The symptoms in these cases of infection were not the usual symptoms of sepsis. We do not know whether using mifepristone and misoprostol caused these deaths.
Patients should contact a healthcare practitioner right away if they have taken these medications for medical abortion and develop stomach pain or discomfort, or have weakness, nausea, vomiting or diarrhea with or without fever, more than 24 hours after taking the misoprostol. These symptoms, even without a fever, may indicate sepsis. Patients should make sure their healthcare practitioner knows they are undergoing a medical abortion.
All providers of medical abortion and emergency room healthcare practitioners should investigate the possibility of sepsis in women who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain. These symptoms even without a fever may indicate a hidden infection. Strong consideration should be given to obtaining a complete blood count in these patients. Significant leukocytosis with a marked left shift and hemoconcentration may be indicative of sepsis.
FDA recommends that healthcare practitioners have a high index of suspicion for serious infection and sepsis in patients with this presentation and consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii.
FDA does not have sufficient information to recommend the use of prophylactic antibiotics for women having a medical abortion. Reports of fatal sepsis in women undergoing medical abortion are very rare (approximately 1 in 100,000). Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics can stimulate the growth of “superbugs,” bacteria resistant to everyday antibiotics. Finally, it is not known which antibiotic and regimen (what dose and for how long) will be effective in cases such as the ones that have occurred.
These recommendations are consistent with warnings in the Prescribing Information and information for the patient in the Medication Guide for Mifeprex.
The approved Mifeprex regimen for a medical abortion through 49 day’s pregnancy is:
* Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
* Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once
* Day 14: Post-Treatment: The patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures.
The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA.
On May 11, 2006, FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), conducted a public workshop. This workshop, entitled “Emerging Clostridial Disease,” discussed the scientific and medical circumstances associated with reports of morbidity and mortality with Clostridium sordellii and Clostridium difficile infections.