Mifepristone (RU 486) in the United States. What does the future hold?

N Engl J Med. 1993 May 27;328(21):1560-1. doi: 10.1056/NEJM199305273282110.

Abstract

PIP: RU-486 or mifepristone developed by Roussel-UCLAF was approved in France in September 1988. Mifepristone coupled with a prostaglandin and administered within 49 days of the last menstrual period produces a complete abortion in about 95% of cases. A new regimen involves supplementing mifepristone with an oral prostaglandin, misoprostol. Mifepristone has been also reported to be effective as a postcoital agent, and it is being evaluated in the treatment of meningioma, recurrent breast cancer, Cushing's syndrome, and glaucoma. Despite these potentially important medical uses, the drug is not available in the US, although its popularity is demonstrated by the large number of women in France who have chosen it over 1st trimester surgical curettage. Many American women prefer a medical abortifacient to be taken privately because of harassment of patients outside abortion facilities; 83% of US countries do not have an abortion facility; a diminishing number of physicians are willing to provide abortion because of the violent protests by antiabortion groups (e.g., the recent murder of Dr. David Gunn); and few residency programs in obstetrics and gynecology routinely offer training in abortion procedures. The manufacturer has restricted the distribution of mifepristone, thus it is available only in France, the UK, and Sweden. The Clinton administration has a pro-choice position, hence Roussel had agreed to grant a license to the Population Council and to provide the Food and Drug Administration with toxicologic and chemical data on mifepristone. Approval will likely take place within 2-3 years. The drug should be used by obstetrician-gynecologists and perhaps by family practitioners and nurse-midwives. Physicians should provide counseling about the side effects and potential complications of abortion. Misoprostol is marketed in the US under the trade name Cytotec, thus its review for use with mifepristone should be simple.

Publication types

  • Comment
  • Editorial

MeSH terms

  • Abortion, Induced*
  • Female
  • France
  • Health Policy*
  • Humans
  • Mifepristone*
  • Misoprostol / administration & dosage
  • Pregnancy
  • Pregnancy Trimester, First
  • United States
  • United States Food and Drug Administration

Substances

  • Misoprostol
  • Mifepristone