Contraception
Volume 81, Issue 1 , Pages 16-21 , January 2010

Postmarketing study of ORTHO EVRA® and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism

  • Susan S. Jick

      Affiliations

    • Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA
    • Department of Epidemiology, Boston University School of Public Health, Boston, MA 02118, USA
    • Corresponding Author InformationCorresponding author. Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, MA 02421, USA. Tel.: +1 781 862 6660; fax: +1 781 862 1680.
    • ,
  • Katrina W. Hagberg

      Affiliations

    • Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA
    • ,
  • Rohini K. Hernandez

      Affiliations

    • Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA
    • Department of Epidemiology, Boston University School of Public Health, Boston, MA 02118, USA
    • ,
  • James A. Kaye

      Affiliations

    • Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA
    • Department of Epidemiology, Boston University School of Public Health, Boston, MA 02118, USA
    • RTI Health Solutions, Waltham, MA 02451-1623, USA

Received 25 June 2009 ,Revised 14 July 2009 ,Accepted 14 July 2009.

References 

  1. Henzl MR, Loomba PK. Transdermal delivery of sex steroids for hormone replacement therapy and contraception. A review of principles and practice. J Reprod Med. 2003;48:525–540
  2. Goa KL, Warner GT, Easthope SE. Transdermal ethinylestradiol/norelgestromin: a review of its use in hormonal contraception. Treat Endocrinol. 2003;2:191–206
  3. Jick SS, Kaye JA, Russmann S, Jick H. Risk of non-fatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 mcg of ethinyl estradiol. Contraception. 2006;73:223–228
  4. Jick SS, Kaye JA, Lin L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 μg of ethinyl estradiol. Contraception. 2007;76:4–7
  5. Jick SS, Jick H. Cerebral venous sinus thrombosis in users of four hormonal contraceptives: levonorgestrel-containing oral contraceptives, norgestimate-containing oral contraceptives, desogestrel-containing oral contraceptives and the contraceptive patch. Contraception. 2006;74:290–292
  6. Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007;109:339–346
  7. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet. 1995;346:1589–1593
  8. Jick H, Kaye JA, Vasilakis-Scaramozza C, Jick SS. Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case-control analysis. BMJ. 2000;321:1190–1195
  9. Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet. 1995;346:1582–1588
  10. Bloemenkamp KWM, Rosendaal FR, Helmerhorst FM, Buller HR, Vandenbroucke JP. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet. 1995;346:1593–1596
  11. Farmer RDT, Lawrenson RA, Thompson CR, Kennedy JG, Hambleton IR. Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet. 1997;349:83–88
  12. Lidegaard O, Edstrom B, Kreiner S. Oral contraceptive and venous thromboembolism. a case-control study. Contraception. 1998;57:291–301
  13. Jick SS, Hagberg KW, Kaye JA, Jick H. Postmenopausal estrogen-containing hormone therapy and the risk of breast cancer. Obstet Gynecol. 2009;113:74–80

☆ This study was funded in part by Johnson & Johnson Pharmaceutical Research & Development, LLC.

PII: S0010-7824(09)00349-7

doi: 10.1016/j.contraception.2009.07.004

Contraception
Volume 81, Issue 1 , Pages 16-21 , January 2010

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