Historical Information on Mifepristone (marketed as Mifeprex)

2006 Information

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

Mifeprex Labeling Change, July 19, 2005

• Healthcare Professional Sheet
• Public Health Advisory
• Questions and Answers
• FDA News: FDA Issues Public Health Advisory for Mifepristone
• Mifeprex Label [PDF]
• Medication Guide [PDF]
• Patient Agreement [PDF]
• 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: FDA To Announce Important Labeling Changes for Mifepristone
• Mifeprex Approval Letter [PDF]
• Mifeprex Label [PDF] (12/22/2004) Revised to add Postmarketing Experience section
• Medication Guide [PDF]
• Patient Agreement Form [PDF]
• Questions and Answers About Mifepristone
• Dear Health Professional Letter [PDF]
• Dear Emergency Room Director [PDF]
  • 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

• Questions and Answers about Mifepristone  (4/17/2002)
• Mifepristone (Mifeprex) Index of Redacted Documents [PDF] (1/30/2002)

September 28, 2000 Information

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

Additional correspondence

 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.