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Safety of mifepristone abortions in clinical use

      Abstract

      Objectives

      Extensive data from clinical trials document mifepristone's safety and efficacy for induced abortion, but less information is available about its safety in routine clinical use.

      Methods

      Data on mifepristone abortion use from the Planned Parenthood Federation of America, the largest provider of mifepristone abortion in the United States, from 2001 through the first quarter of 2004 were collected using a centralized reporting system. Over the study period, 95,163 mifepristone abortions were provided. Reportable events are complications requiring inpatient or outpatient hospital treatment.

      Results

      Overall, 2.2 per 1000 women (95% CI 1.9���2.5) experienced a complication, most commonly, heavy bleeding. Mifepristone abortion mortality is estimated to be 1.1 per 100,000 based on one death (95% CI 0.3���5.9).

      Conclusions

      The safety of mifepristone is high; few serious medical complications occur in routine clinical use.

      Keywords

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      References

        • Peyron R.
        • Aubeny E.
        • Targosz V.
        • et al.
        Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol.
        N Engl J Med. 1993; 328: 1509-1513
        • Winikoff B.
        • Sivin I.
        • Coyaji K.J.
        • et al.
        Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone���misoprostol versus surgical abortion.
        Am J Obstet Gynecol. 1997; 176: 431-437
        • Spitz I.M.
        • Bardin C.W.
        • Benton L.
        • Robbins A.
        Early pregnancy termination with mifepristone and misoprostol in the United States.
        N Engl J Med. 1998; 338: 1241-1247
        • Ashok P.W.
        • Penney G.C.
        • Flett G.M.
        • Templeton A.
        An effective regimen for early medical abortion: a report of 2000 consecutive cases.
        Hum Reprod. 1998; 13: 2962-2965
        • Schaff E.A.
        • Stadalius L.S.
        • Eisinger S.H.
        • Franks P.
        Vaginal misoprostol administered at home after mifepristone (RU486) for abortion.
        J Fam Pract. 1997; 44: 353-360
        • Schaff E.A.
        • Fielding S.L.
        • Westhoff C.
        Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy.
        Contraception. 2002; 66: 247-250
        • El-Refaey H.
        • Rajasekar M.
        • Abdalla M.
        • Calder L.
        • Templeton A.
        Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol.
        N Engl J Med. 1995; 322: 983-987
        • Schaff E.A.
        • Fielding S.L.
        • Westhoff C.
        Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion.
        Contraception. 2001; 64: 81-85
        • Schaff E.A.
        • Eisinger S.H.
        • Stadalius L.S.
        • Franks P.
        • Gore B.Z.
        • Poppema S.
        Low-dose mifepristone 200 mg and vaginal misoprostol for abortion.
        Contraception. 1999; 59: 1-6
        • Schaff E.A.
        • Fielding S.L.
        • Westhoff C.
        • et al.
        Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: a randomized trial.
        JAMA. 2000; 284: 1948-1953
        • Creinin M.D.
        • Fox M.C.
        • Teal S.
        • Chen A.
        • Schaff E.A.
        • Meyn L.A.
        A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion.
        Obstet Gynecol. 2004; 103: 850-859
        • Shannon C.S.
        • Winikoff B.
        • Hausknecht R.
        • et al.
        Multicenter trial of a simplified mifepristone medical abortion regimen.
        Obstet Gynecol. 2005; 105: 345-351
        • Prine L.
        • Lesnewski R.
        • Berley N.
        • Gold M.
        Medical abortion in family practice: a case series.
        J Am Board Fam Pract. 2003; 16: 290-295
        • Creinin M.D.
        • Potter C.
        • Holovanisin M.
        • et al.
        Mifepristone and misoprostol and methotrexate/misoprostol in clinical practice for abortion.
        Am J Obstet Gynecol. 2003; 188: 664-669
        • Hausknecht R.
        Mifepristone and misoprostol for early medical abortion: 18 months experience in the United States.
        Contraception. 2003; 67: 463-465
        • Henshaw S.K.
        • Finer L.B.
        The accessibility of abortion services in the United States, 2001.
        Perspect Sex Reprod Health. 2003; 35: 16-24
        • Shannon C.
        • Brothers L.P.
        • Philip N.M.
        • Winikoff B.
        Infection after medical abortion: a review of the literature.
        Contraception. 2004; 70: 183-190
        • Schaff E.A.
        • Fielding S.L.
        • Eisinger S.H.
        • Stadalius L.S.
        • Fuller L.
        Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days.
        Contraception. 2000; 61: 41-46
        • Stubblefield P.G.
        • Carr-Ellis S.
        • Borgatta L.
        Methods for induced abortion.
        Obstet Gynecol. 2004; 104: 174-185
        • Sinave C.
        • Templier G.L.
        • Blouin D.
        • L��veill�� F.
        • Deland ��.
        Toxic shock syndrome due to Clostridium sordellii: a dramatic postpartum and postabortion disease.
        Clin Infect Dis. 2002; 35: 1441-1443
      1. Elam-Evans L, Strauss L, Herndon J, Parker W, Whitehead S, Berg C, Abortion surveillance ��� United States, 1999. MMWR Surveill Summ 2002; 51: 1���9, 11���28.

        • Bartlett L.
        • Berg C.
        • Shulman H.
        • et al.
        Risk factors for legal induced abortion-related mortality in the United States.
        Obstet Gynecol. 2004; 103: 729-737
        • Chang J.
        • Elam-Evans L.
        • Berg C.
        • et al.
        Pregnancy-related mortality surveillance ��� United States, 1991���1999.
        MMWR Morb Mortal Wkly Rep. 2003; 52: 1-14