Contraception
Volume 81, Issue 5 , Pages 408-413 , May 2010

Extended case-control study results on thromboembolic outcomes among transdermal contraceptive users

  • David D. Dore

      Affiliations

    • i3 Drug Safety, Waltham, MA 02451, USA
    • Department of Community Health, The Warren Alpert Medical School of Brown University, Providence, RI 02912, USA
    • Corresponding Author InformationCorresponding author. i3 Drug Safety, Waltham, MA 02451, USA. Tel.: +1 781 472 8497; fax: +1 781 472 8464.
    • ,
  • Heather Norman

      Affiliations

    • i3 Drug Safety, Waltham, MA 02451, USA
    • ,
  • Jeanne Loughlin

      Affiliations

    • i3 Drug Safety, Waltham, MA 02451, USA
    • ,
  • John D. Seeger

      Affiliations

    • i3 Drug Safety, Waltham, MA 02451, USA
    • Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, USA

Received 11 November 2009 ,Accepted 9 December 2009.

References 

  1. 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
  2. Cole JA, Norman H, Doherty M, Walker AM. Corrections. Obstet Gynecol. 2008;111:1449
  3. Dore DD, Norman H, Seeger JD. Eligibility criteria in venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2009;114:175
  4. Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73:223–228
  5. Jick S, Kaye JA, Li 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 microg of ethinyl estradiol. Contraception. 2007;76:4–7
  6. Jick SS, Jick H. The contraceptive patch in relation to ischemic stroke and acute myocardial infarction. Pharmacotherapy. 2007;27:218–220
  7. van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinyl estradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72:168–174
  8. National Death Index . National Center for Health Statistics. Available from: http://www.cdc.gov/nchs/ndi.htm[Accessed 22 May 2009]
  9. Crystal S, Akincigil A, Bilder S, Walkup JT. Studying prescription drug use and outcomes with Medicaid claims data: strengths, limitations, and strategies. Med Care. 2007;45:S58–65
  10. Walker AM. Pattern recognition in health insurance claims databases. Pharmacoepidemiol Drug Saf. 2001;10:393–397
  11. Jurek AM, Greenland S, Maldonado G. How far from non-differential does exposure or disease misclassification have to be to bias measures of association away from the null?. Int J Epidemiol. 2008;37:382–385
  12. Phelps JY, Kelver ME. Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation. Obstet Gynecol. 2009;113:712–716

☆ This study was funded by a research contract between i3 Drug Safety and Johnson & Johnson Pharmaceutical Research & Development, LLC. The contract granted i3 Drug Safety oversight of the study conduct, reporting and interpretation, as well as final wording of any resulting manuscripts.

☆☆ An abstract (<300 words) of this paper was presented at the International Society for Pharmacoepidemiology's annual meeting in August 2009 in Providence, RI.

★ Disclosures: Dr. Dore, Ms. Norman, Ms. Loughlin and Dr. Seeger are employees of i3 Drug Safety and holders of stock and stock options in UnitedHealth Group (the parent corporation of i3 Drug Safety).

PII: S0010-7824(09)00527-7

doi: 10.1016/j.contraception.2009.12.009

Contraception
Volume 81, Issue 5 , Pages 408-413 , May 2010

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