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


METHODS
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.


CONCLUSIONS
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.
Jick
Susan S
SS
Boston Collaborative Drug Surveillance Program, Department of Epidemiology, Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421, USA. sjick@bu.edu
Hagberg
Katrina W
KW
Hernandez
Rohini K
RK
Kaye
James A
JA
D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D016001:Confidence Intervals; D003276:Contraceptives, Oral / Q000009:adverse effects; D016208:Databases, Factual / Q000706:statistics & numerical data; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D016912:Levonorgestrel / Q000009:adverse effects*; D009644:Norgestrel / Q000009:adverse effects / Q000031:analogs & derivatives*; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D014481:United States; D054556:Venous Thromboembolism / Q000453:epidemiology* / Q000209:etiology*
D003276:Contraceptives, Oral; D004338:Drug Combinations; C511292:Ortho Evra; D009644:Norgestrel; D004997:Ethinyl Estradiol; D016912:Levonorgestrel