Who Should Not Take RU-486

The FDA advises that RU-486 should NOT be taken if any one of the following circumstances apply:
  • "It has been more than 49 days ... since your last menstrual period began.
  • You have an IUD. It must be taken out. ...
  • Your provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy). [Note: About 2% of pregnancies are outside the uterus.13 ]
  • You have problems with your adrenal glands (chronic adrenal failure).
  • You take a medicine to thin your blood.
  • You have a bleeding problem.
  • You take certain steroid medications.
  • You cannot return for the next 2 visits [2 days and 14 days after taking RU-486].
  • You cannot easily get emergency medical help [including 'blood transfusions, and emergency resuscitation'14 ] in the 2 weeks after you take [RU-486].
  • You are allergic to mifepristone [RU-486], misoprostol, or medicines that contain misoprostol such as Cytotec or Arthrotec."15

FDA records explain that women also were excluded from the U.S. trials of RU-486 due to possible health risks if they were
  • under 18 years of age or
  • over 35 and smoked more than 10 cigarettes a day or
  • if they lived or worked more than one hour from the emergency facility that served the abortion facility conducting the trial or
  • if they had any of the following conditions:
    • asthma
    • glaucoma
    • mitral stenosis
    • arterial hypotension
    • sickle cell anemia
    • history of severe liver, respiratory or renal disease or thromboembolism
    • insulin-dependent diabetes
    • cardiovascular disease, e.g. angina, valve disease, arrhythmia, cardiac failure
    • hypertension
    • blood pressure over 140/90mmHg
    • anemia
    • adnexal masses or tenderness on pelvic examination that suggested pelvic inflammatory disease16

13 Ectopic Pregnancy - United States, 1990-1992. Morbidity and Mortality Weekly Report 1995; 44:46-48. See also, F. Gary Cunningham et al., "Chapter 34: Ectopic Pregnancy," Williams Obstetrics, 21st ed., New York: McGraw-Hill, 2001; 883,at 885.

14 Mifeprex label, available at http://www.fda.gov/cder/foi/label/2000/20687lbl.htm.

15 FDA CDER, "Mifepristone Medication Guide," supra note 7.

16 Medical Officer's Review, supra note 8, at 8-9.