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Depo-Provera's black box: time to reconsider?

      Currently, over 2 million U.S. women, including many in their teenage years, use injectable depot medroxyprogesterone acetate (DMPA, Depo-Provera) [
      • Mosher W.D.
      • Martinez G.M.
      • Chandra A.
      • Abma J.C.
      • Willson S.J.
      Use of contraception and use of family planning services in the United States, 1982���2002. Advance data from vital and health statistics; no 350.
      ]. However, the United States Food and Drug Administration's (FDA) recent regulatory action regarding DMPA and skeletal health makes it likely that there will be a sharp decline in the use of this effective, convenient birth control option. A review of available evidence regarding progestin use, estradiol levels and long-term skeletal health suggests that the FDA's recent additional labeling for DMPA is unnecessary and should be revised or rescinded.
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      References

        • Mosher W.D.
        • Martinez G.M.
        • Chandra A.
        • Abma J.C.
        • Willson S.J.
        Use of contraception and use of family planning services in the United States, 1982���2002. Advance data from vital and health statistics; no 350.
        National Center for Health Statistics, Hyattsville (Md)2004
        • Mishell Jr., D.R.
        • Kharma K.M.
        • Thorneycroft I.H.
        • Nakamura R.M.
        Estrogenic activity in women receiving an injectable progestogen for contraception.
        Am J Obstet Gynecol. 1972; 113: 372-376
        • Cundy T.
        • Evans M.
        • Roberts H.
        • Wattie D.
        • Ames R.
        • Reid I.R.
        Bone density in women receiving depot medroxyprogesterone acetate for contraception.
        BMJ. 1991; 208: 13-16
        • Kaunitz A.M.
        Injectable contraception ��� new and existing options.
        Obstet Gynecol Clin North Am. 2000; 27: 741-780
        • Banks E.
        • Berrington A.
        • Casabonne D.
        Overview of the relationship between use of progestogen-only contraceptives and bone mineral density.
        BJOG. 2001; 108: 1214-1221
        • Westhoff C.L.
        Depot-medroxyprogesterone acetate injection (Depo-Provera): a highly effective contraceptive option with proven long-term safety.
        Contraception. 2003; : 6875-6887
        • Cundy T.
        • Cornish J.
        • Evans M.C.
        • Roberts H.
        • Reid I.C.
        Recovery of bone density in women who stop using medroxyprogesterone acetate.
        BMJ. 1994; 308: 247-248
      1. ([last accessed February 12, 2005])
        • Pettiti D.B.
        • Piaggio G.
        • Mehta S.
        • Cavioto M.C.
        • Meirik O.
        Steroid hormone contraception and bone mineral density: a cross-sectional study in an international population: the WHO Study of Hormonal Contraception and Bone Health.
        Obstet Gynecol. 2000; 95: 736-744
        • Orr-Walker B.J.
        • Evans M.C.
        • Ames R.W.
        • Clearwater J.M.
        • Cundy T.
        • Reid I.R.
        The effect of past use of the injectable contraceptive depot medroxyprogesterone acetate on bone mineral density in normal post-menopausal women.
        Clin Endocrinol (Oxf). 1998; 49: 615-618
        • Scholes D.
        • LaCroix A.Z.
        • Ichikawa L.E.
        • Barlow W.E.
        • Ott S.M.
        Injectable hormone contraception and bone density: results from a prospective study.
        Epidemiology. 2002; 13: 581-587
        • Abma J.C.
        • Martinez G.M.
        • Mosher W.D.
        • Dawson B.S.
        Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2002. National Center for Health Statistics.
        Vital Health Stat. 2004; 23 ([last accessed 5/26/05]): 1-48
        • Scholes D.
        • LaCroix A.Z.
        • Ichikawa L.E.
        • Barlow W.E.
        • Ott S.M.
        Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception.
        Arch Pediatr Adolesc Med. 2005; 159: 139-144
        • Cundy T.
        • Ames R.
        • Horne A.
        • et al.
        A randomized controlled trial of estrogen replacement therapy in long-term users of depot medroxyprogesterone acetate.
        J Clin Endocrinol Metab. 2003; 88: 78-81
        • Kaunitz A.M.
        • Garceau R.J.
        • Cromie M.A.
        • the Lunelle Study Group
        Comparative safety, efficacy, and cycle control of Lunelle��� monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum�� 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic).
        Contraception. 1999; : 60179-60187
        • Cromer B.A.
        • Lazebnik R.
        • Rome E.
        • et al.
        Double-blinded randomized controlled trial of estrogen supplementation in adolescent girls who receive depot medroxyprogesterone acetate for contraception.
        Am J Obstet Gynecol. 2005; 192: 42-47
        • Kaunitz A.M.
        Long-acting hormonal contraception: assessing impact on bone-density, weight, and mood.
        Int J Fertil. 1999; 44: 110-117
        • Kalkwarf H.J.
        • Specker B.L.
        • Bianchi D.C.
        • Ranz J.
        • Ho M.
        Bone mineral loss during lactation and recovery after weaning.
        N Engl J Med. 1997; 337: 523-528
        • Polatti F.
        • Capuzzo E.
        • Viazzo F.
        • Colleoni R.
        • Lersy C.
        Bone mineral changes during and after lactation.
        Obstet Gynecol. 1999; 94: 52-56
        • Sowers M.F.
        • Corton G.
        • Shapiro B.
        • et al.
        Changes in bone density with lactation.
        JAMA. 1993; 269: 3130-3135
        • Michaelsson K.
        • Baron J.A.
        • Farahmand L.
        Influence of parity and lactation on hip fracture risk.
        Am J Epidemiol. 2001; 153: 1166-1172
        • Chantry C.J.
        • Auinger P.
        • Byrd R.S.
        Lactation among adolescent mothers and subsequent bone mineral density.
        Arch Pediatr Adolesc Med. 2004; 158: 650-656
        • Grimes D.A.
        • Schultz K.
        Surrogate end points in clinical research: hazardous to your health.
        Obstet Gynecol. 2005; 105: 1114-1118
        • Centers for Disease Control
        Achievements in public health, 1990���1999: family planning.
        MMWR Morb Mortal Wkly Rep. 1999; 48: 1073-1080