Am Fam Physician. 2006 May 15;73(10):1703-1704.
to the editor: I would like to clarify the use of mifepristone (Mifeprex) in the treatment of ectopic pregnancy mentioned in the article, “Diagnosis and Management of Ectopic Pregnancy,”1 by Drs. Lozeau and Potter that appeared in the November 1, 2005, issue of American Family Physician. In a study2 of 212 patients randomized to treatment of mifepristone plus methotrexate or methotrexate and placebo, the success rate of combination therapy was 83.0 percent compared with 38.5 percent in those receiving methotrexate alone when the progesterone level was greater than 10 ng per mL (31.8 nmol per L). Another study3 found that combination therapy resulted in a somewhat faster resolution of the ectopic pregnancy, most notably in women with a higher quantitative beta subunit of human chorionic gonadotropin (beta-hCG).
One small study4 showed that the combination of oral mifepristone and methotrexate resulted in a higher success rate overall than methotrexate alone, whereas another study5 showed that 37 of 38 patients with ectopic pregnancy were successfully treated with mifepristone alone.
However, the U.S. Food and Drug Administration (FDA) label for Mifeprex lists ectopic pregnancy as a contraindication to its administration. The FDA states that “mifepristone is not effective for the treatment of ectopic pregnancy,” and also recently issued a warning about sepsis occurring after medical abortions with mifepristone.6 It certainly seems unwise to use mifepristone to treat ectopic pregnancy from a medicolegal standpoint, and the additional efficacy of combined methotrexate/mifepristone regimens may not justify the increased infectious risk to the patient.
Patient education is an essential part of any conservative regimen for the treatment of ectopic pregnancy. The patient must be aware of the possibility of medication failure and the absolute requirement for follow-up visits. Access to timely surgical treatment must exist to ensure maximal patient safety.
1. Lozeau A, Potter B. Diagnosis and management of ectopic pregnancy. Am Fam Physician. 2005;72:1707–14.
2. Rozenberg P, Chevret S, Camus E, de Tayrac R, Garbin O, de Poncheville L, et al. Medical treatment of ectopic pregnancies: a randomized clinical trial comparing methotrexate-mifepristone and methotrexate-placebo. Hum Reprod. 2003;18:1802–8.
3. Gazvani MR, Baruah DN, Alfirevic Z, Emery SJ. Mifepristone in combination with methotrexate for the medical treatment of tubal pregnancy: a randomized, controlled trial. Hum Reprod. 1998;13:1987–90.
4. Perdu M, Camus E, Rozenberg P, Goffinet F, Chastang C, Philippe HJ, et al. Treating ectopic pregnancy with the combination of mifepristone and methotrexate: a phase II nonrandomized study. Am J Obstet Gynecol. 1998;179:640–3.
5. Zhang W, Wang L. Mifepristone in treating ectopic pregnancy. Chin Med J (Engl). 1999;112:376–8.
6. Labeling changes for mifepristone. FDA Consum. 2005 Jan–Feb;39:5.
in reply: We thank Dr. Grossman for bringing this important information to our attention. There have been four reported cases of sepsis that have resulted in death in women receiving the combination of mifepristone (Mifeprex) followed by misoprostol (Cytotec).1,2 Thus, the U.S. Food and Drug Administration has issued a warning against its use in ectopic pregnancy or therapeutic abortion.3 In light of this information, we agree that mifepristone should not be used in the treatment of ectopic pregnancy or medical abortion.
1. Fischer M, Bhatnagar J, Guarner J, Reagan S, Hacker JK, Van Meter SH, et al. Fatal toxic shock syndrome associated withClostridium sordellii after medical abortion. N Engl J Med. 2005;353:2352–60.
2. Greene MF. Fatal infections associated with mifepristone-induced abortion. N Engl J Med. 2005;353:2317–8.
3. Mifeprex (mifepristone) information. FDA alert. U.S. Food and Drug Administration. July 19, 2005. Accessed February 21, 2006, at: http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.
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