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FDA Public Health Advisory on RU 486

Sepsis and Medical Abortion Update

March 17, 2006

The Food and Drug Administration has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex).  The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories.  At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death.  However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment.  In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

The approved Mifeprex regimen for a medical abortion through 49 days’ 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.

These recommendations are consistent with warnings in the Prescribing Information and information for the patient in the Medication Guide.  FDA also emphasizes that healthcare professionals and patients should be aware of the following:

All providers of medical abortion and emergency room health care providers should investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after taking misoprostol. To help identify those patients with hidden infection, strong consideration should be given to obtaining a complete blood count.
 

FDA recommends that physicians suspect infection 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. 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.

As previously provided in our July 19, 2005 Public Health Advisory, updated on November 4, 2005, the Agency is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone (Mifeprex) and misoprostol.   All four cases of fatal infection tested positive for Clostridium sordellii.   All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol.  In addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii.  

We do not know whether these new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordellii. However, FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), is conducting a public workshop on May 11, 2006. This scientific workshop entitled, “Emerging Clostridial Disease,” at the CDC Conference Center, Atlanta, Georgia, is being conducted to discuss the scientific and medical circumstances associated with reports of morbidity and mortality associated with C. sordellii and C difficile infections.  These reports include cases and clusters of C. sordellii toxic shock syndrome following treatment with mifepristone, C. sordellii sepsis associated with skin grafts, and rapidly fatal toxin-mediated cases of community-associated C. difficile infection.  The primary goal of the workshop is to bring together scientific and public health experts to develop a draft research agenda leading to a better understanding of the virulence, pathogenesis, host factors, and non-antimicrobial risk factors contributing to those reports.   

Information pertaining to Mifeprex can be found at http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm
 

Information pertaining to Emerging Clostridial Diseases Public Workshop can be found at   http://www.fda.gov/cder/meeting/clostridia_disease.htm

 

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