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March 17th: Sepsis and Medical Abortion Update

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. were investigating all circumstances associated with these cases and were 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.

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.

For approved Mifeprex regimen and prescribing and patient information, please refer following links:
http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm

If you have comments regarding this update, please email us at info@mdiconsultants.com
 

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