health and illness: March 2006 Archives

letter from the FDA


responding to a request to take RU-486 (mifeprex) off the market.

Thank you for your message to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).

As you know, 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.

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.

You may read more about this topic at the following site

CDER/Division of Drug Information bmd
Disclaimer: This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


| | TrackBacks (1)

quick update

| | Comments (3)

The allergic reaction that hit me last Sunday took the form of severe swelling around one eye - to the point that the eyelid was swollen almost shut. It also itched like crazy inside my ear canal and I felt like fertilizer. Monday I broke down and went to the doctor who put me on steroids. I made it into work Tuesday and yesterday as well but I am still not quite myself.
I got a reply from NPR about the letter to the editor I sent a couple of weeks ago. Plan to blog it with some more comments when I have the energy. And I still haven't forgotten that I was going to talk about the 'chastity' talk that the confirmation kids got a few weeks ago.
Hope that your Lents have been fruitful. Mine has given me lots of opportunities for prayer that I would not have sought out for myself.

dad update

| | Comments (2)

email from my sister:

Dad went home from the hospital Friday night and spent most of Saturday getting re-settled, He’s all settled now and just waiting for Monday for all the specialists to start calling and showing up to provide the supports that were available in the hospital i.e. nursing and physical therapy.

February 2013

Sun Mon Tue Wed Thu Fri Sat
          1 2
3 4 5 6 7 8 9
10 11 12 13 14 15 16
17 18 19 20 21 22 23
24 25 26 27 28    
The WeatherPixie

About this Archive

This page is a archive of entries in the health and illness category from March 2006.

health and illness: February 2006 is the previous archive.

health and illness: April 2006 is the next archive.

Find recent content on the main index or look in the archives to find all content.