Label Changes for:

Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)

January 2008

Changes have been made to the WARNINGS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Epidemiologic, case-control studies...
    • Table 5

PATIENT PACKAGE INSERT: DETAILED PATIENT LABELING

  • Other Considerations Before Using Ortho Evra

WARNINGS

Epidemiologic, case-control studies were conducted in the U.S. using electronic healthcare claims data to evaluate the risk of venous thromboembolism (VTE) among women aged 15-44 who used Ortho Evra compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either norgestimate (NGM) or levonorgestrel (LNG). NGM is the prodrug for norelgestromin, the progestin in Ortho Evra. These studies (see Table 5) used slightly different designs and reported odds ratios ranging from 0.9 (indicating no increase in risk) to 2.4 (indicating an approximate doubling of risk). One study (i3 Ingenix) included patient chart review to confirm the VTE occurrence...

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