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

AbstractBACKGROUND:
Concern has been raised that the risk of venous thromboembolism (VTE) in users of the ORTHO EVRA patch is higher compared to users of oral contraceptives (OCs).
STUDY DESIGN:
We identified idiopathic cases of VTE and controls, matched on age and index date, from among women in the United States PharMetrics/IMS and MarketScan databases who were current users of the patch or levonorgestrel-containing OCs with 30 mcg of ethinyl estradiol. We calculated odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS:
The ORs (95% CI) for VTE in users of the patch compared to levonorgestrel-containing OCs were 2.0 (0.9-4.1) and 1.3 (0.8-2.1) in the PharMetrics and MarketScan databases, respectively. ORs (95% CI) restricted to women aged 39 years or younger were 1.4 (0.6-3.0) and 1.2 (0.7-2.0), respectively.
CONCLUSION:
These results provide evidence that the risk of idiopathic VTE in users of the patch is not materially different than that of users of levonorgestrel-containing OCs in women aged 39 years or younger. We cannot rule out some increase in the risk in women aged 40 years or older.
AuthorsSusan S Jick, Katrina W Hagberg, Rohini K Hernandez, James A Kaye
JournalContraception (Contraception) Vol. 81 Issue 1 Pg. 16-21 (Jan 2010) ISSN: 1879-0518 [Electronic] United States
PMID20004268 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Contraceptives, Oral
  • Ortho Evra
  • Norgestrel
  • Ethinyl Estradiol
  • Levonorgestrel
Topics
  • Adolescent
  • Adult
  • Case-Control Studies
  • Confidence Intervals
  • Contraceptives, Oral (adverse effects)
  • Databases, Factual (statistics & numerical data)
  • Ethinyl Estradiol (adverse effects)
  • Female
  • Humans
  • Incidence
  • Levonorgestrel (adverse effects)
  • Norgestrel (adverse effects, analogs & derivatives)
  • Odds Ratio
  • Product Surveillance, Postmarketing
  • United States
  • Venous Thromboembolism (epidemiology, etiology)

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