Letters to the Editor
Use of Mifepristone for Treatment of Ectopic Pregnancy
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.
REFERENCES
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.
REFERENCES
1. Fischer M, Bhatnagar J, Guarner J, Reagan S, Hacker JK, Van Meter SH, et al. Fatal toxic shock syndrome associated with Clostridium 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.
The article "Initial Evaluation of Vertigo" (January 15, 2006, page 244) contained an error in the definition of otosclerosis listed in Table 1 (page 246). The correct definition for otosclerosis is: Abnormal growth of bone in the middle ear, leading to immobilization of the bones of conduction and a conductive hearing loss. This process also may affect the cochlea, leading to tinnitus, vertigo, and sensorineural hearing loss. The online version of this article has been corrected.
The article "Preventive Counseling, Screening, and Therapy for the Patient with Newly Diagnosed HIV Infection" (January 15, 2006, page 271) contained an error in the last recommendation of the "SORT: Key Recommendations for Practice" table regarding the CD4+ cell counts at which antibiotic prophylaxis for toxoplasmosis and Mycobacterium avium-intracellulare complex should be initiated (the cutoffs were inadvertently transposed). The recommendation should have read as follows: "Antibiotic prophylaxis should be used to prevent toxoplasmosis and Mycobacterium avium-intracellulare complex infection at CD4+ cell counts below 100 and below 50 cells per mm3, respectively." The online version of this article has been corrected and the corrected SORT table appears below.
|
SORT: Key Recommendations for Practice |
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|
Clinical recommendation |
Evidence rating |
References |
|
Patients with HIV should be monitored for CD4+ lymphocyte and HIV RNA levels every three to six months. |
C |
7, 8, 26, 28 |
|
Patients who are hepatitis A or B nonimmune at baseline should be vaccinated. |
B |
7, 8, 25 |
|
Tuberculosis prophylaxis should be given to patients with any of the following: history or symptoms of tuberculosis, a PPD of at least 5 mm, or a possible false-negative PPD. |
C |
7, 8, 25 |
|
Pneumocystis jiroveci prophylaxis with trimethoprim/sulfamethoxazole (Bactrim, Septra) should be initiated at CD4+ counts of less than 200 cells per mm3. |
A |
7, 8, 25 |
|
Women with HIV should have Pap smears every six months for the first year and, if normal, annual Pap smears thereafter. |
C |
7, 8, 25 |
|
High-risk patients with ongoing exposure should be checked annually for gonorrhea, chlamydia, syphilis, and hepatitis C. |
C |
7, 8, 25 |
|
Antibiotic prophylaxis should be used to prevent toxoplasmosis and Mycobacterium avium-intracellulare complex infection at CD4+ cell counts below 100 and below 50 cells per mm3, respectively. |
B |
7, 8, 25 |
| HIV = human immunodeficiency virus; PPD = purified protein derivative; Pap = Papanicolaou. A = consistent, good-quality patient-oriented evidence; B = inconsistent or limited-quality patient-oriented evidence; C = consensus, disease-oriented evidence, usual practice, expert opinion, or case series. For information about the SORT evidence rating system, see http://www.aafp.org/afpsort.xml. |
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Send letters to Kenny Lin, M.D., assistant editor, American Family Physician, e-mail: afplet@aafp.org. Letters submitted via regular mail should be sent (on disk) to: 11400 Tomahawk Creek Pkwy., Leawood, KS 66211-6272.
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