2006 Information

• Public Health Advisory, 3/17/2006
• 2005 and 2006 FDA Alerts and Updates on Mifeprex

Mifeprex Labeling Change, July 19, 2005

• Patient Information Sheet
• Healthcare Professional Sheet
• Public Health Advisory
• Questions and Answers
• Dear Healthcare Provider Letter
• FDA News
• Mifeprex Label
• Medication Guide
• Patient Agreement
• Journal Articles
  • Fischer M, Bhatnagar J, Guarner J, Reagan S, Hacker JK, Van Meter SH, Poukens V, Whiteman DB, Iton A, Cheung M, Dassey DE, Shieh WJ, Zaki SR. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med. 2005 Dec 1;353(22):2352-60.  Abstract
    
  • Greene MF. Fatal infections associated with mifepristone-induced abortion. N Engl J Med. 2005 Dec 1;353(22):2317-8. No abstract available

November 15, 2004 Information

• FDA Statement
• Mifeprex Approval Letter
• Mifeprex Label (12/22/2004) Revised to add Postmarketing Experience section
• Medication Guide [HTML] or [PDF]
• Patient Agreement Form
• Questions and Answers About Mifepristone
• Dear Health Professional Letter
• Dear Emergency Room Director
  • Book chapter cited in the above letters: Phillip G. Stubblefield, MD and Lynn Borgatta, MD, “Complications of Induced Abortion” in Mark D. Pearlman, Judith E. Tintinalli, Pamela L. Dyne, Obstetric & Gynecologic Emergencies Diagnosis and Management, (New York: McGraw-Hill, 2004), 65-86.

2002 Information

• Dear Healthcare Professional Letter  
• Questions and Answers about Mifepristone  (4/17/2002)
• Mifepristone (Mifeprex) Index of Redacted Documents (1/30/2002)

September 28, 2000 Information

• Press Release on Mifepristone Approval
• Mifepristone Approval Letter 9/28/2000.   Optional Format: PDF 
• Mifepristone Label.  Optional Format: PDF
• Mifepristone Medication Guide
• Questions and Answers about Mifepristone
• Patient Agreement Form
• Prescriber's Agreement Form
• Mifepristone Review
• Office Memo to Population Council

Federal Register Final Rule, Restrictions on Use After Marketing (12/2/1992)

Report Adverse Events to MedWatch  

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