Postmarketing study of ORTHO EVRA® and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism☆
Received 25 June 2009; received in revised form 14 July 2009; accepted 14 July 2009. published online 25 August 2009.
Abstract
Background
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.
aBoston Collaborative Drug Surveillance Program, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA
bDepartment of Epidemiology, Boston University School of Public Health, Boston, MA 02118, USA
cRTI Health Solutions, Waltham, MA 02451-1623, USA
Corresponding 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.
☆ This study was funded in part by Johnson & Johnson Pharmaceutical Research & Development, LLC.
ABSTRACT