Guest guest Posted November 16, 2004 Report Share Posted November 16, 2004 - Ralph Rowe Undisclosed-Recipient:; Monday, November 15, 2004 9:53 PM Take the 'Morning After' pill and die... Freedom America NOW E-List - News and Views From New BabylonThe beast is loose in Bethlehem and the rats are in the corn.Look up... for your redemption draweth nigh!++++++Jesus Christ is the Answer, Check it out.++++++ http://www.fda.gov/bbs/topics/news/2004/NEW01134.html FDA Statement FOR IMMEDIATE RELEASEStatementNovember 15, 2004 Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA FDA To Announce Important Labeling Changes for Mifepristone The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling. The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all. The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies (tubal pregancies) as this condition may be missed by physicial examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for termination of these pregnancies. For consumers, the Medication Guide states they should contact their health care provider right away for fever, abdominal pain, and heavy bleeding. Also, consumers are advised to take their Medication Guide to the emergency room or any health care provider they visit for problems. This allows health care providers to understand that the patient is undergoing a termination of pregnancy, and assess risks associated with that condition. The revised labeling will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion. FDA will continue to monitor the usage of Mifeprex and may take further action. #### More Information ________________A Cherokee elder was teaching his grandchildren about life. He said to them, "Afight is going on inside me...It is a terrible fight between two wolves. One wolfrepresents fear, anger, envy, sorrow, regret, greed, arrogance, self-pity, guilt,resentment, inferiority, lies, pride and superiority. The other wolf stands for joy,peace, love, hope, sharing, serenity, humility, kindness, benevolence, friendship,empathy, generosity, truth, compassion, and faith. This same fight is going oninside of you and every other person too." --They thought about it for a minute and then one child asked; "Grandfather,which wolf will win?" The old man simply replied... "The one I feed." ..Anon MOLON LABE! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 16, 2004 Report Share Posted November 16, 2004 hmmmm... I wonder if its for real or some more of Bush's Bible Fantasy Land manipulations.... not like we can trust anything the FDA puts out... CHEROKEE <cherokee wrote: - Ralph Rowe Undisclosed-Recipient:; Monday, November 15, 2004 9:53 PM Take the 'Morning After' pill and die... Freedom America NOW E-List - News and Views From New BabylonThe beast is loose in Bethlehem and the rats are in the corn.Look up... for your redemption draweth nigh!++++++Jesus Christ is the Answer, Check it out.++++++ http://www.fda.gov/bbs/topics/news/2004/NEW01134.html FDA Statement FOR IMMEDIATE RELEASEStatementNovember 15, 2004 Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA FDA To Announce Important Labeling Changes for Mifepristone The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling. The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all. The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies (tubal pregancies) as this condition may be missed by physicial examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for termination of these pregnancies. For consumers, the Medication Guide states they should contact their health care provider right away for fever, abdominal pain, and heavy bleeding. Also, consumers are advised to take their Medication Guide to the emergency room or any health care provider they visit for problems. This allows health care providers to understand that the patient is undergoing a termination of pregnancy, and assess risks associated with that condition. The revised labeling will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion. FDA will continue to monitor the usage of Mifeprex and may take further action. #### More Information ________________A Cherokee elder was teaching his grandchildren about life. He said to them, "Afight is going on inside me...It is a terrible fight between two wolves. One wolfrepresents fear, anger, envy, sorrow, regret, greed, arrogance, self-pity, guilt,resentment, inferiority, lies, pride and superiority. The other wolf stands for joy,peace, love, hope, sharing, serenity, humility, kindness, benevolence, friendship,empathy, generosity, truth, compassion, and faith. This same fight is going oninside of you and every other person too." --They thought about it for a minute and then one child asked; "Grandfather,which wolf will win?" The old man simply replied... "The one I feed." ..Anon MOLON LABE!«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§ - PULSE ON WORLD HEALTH CONSPIRACIES! §Subscribe:......... - To :.... - Any information here in is for educational purpose only, it may be news related, purely speculation or someone's opinion. Always consult with a qualified health practitioner before deciding on any course of treatment, especially for serious or life-threatening illnesses.**COPYRIGHT NOTICE**In accordance with Title 17 U.S.C. Section 107,any copyrighted work in this message is distributed under fair use without profit or payment to those who have expressed a prior interest in receiving the included information for non-profit research and educational purposes only. http://www.law.cornell.edu/uscode/17/107.shtml Meet the all-new My – Try it today! Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.