Ortho Evra (norelgestromin / ethinyl estradiol transdermal system) October 2008
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.|
Summary of Changes to Contraindications and Warnings
PATIENT PACKAGE INSERT
WARNINGS (See highlighted prescribing information for revised text).
Epidemiologic, case-control studies107-111 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 to 2.4. The interpretations of these odds ratios range from no increase in risk to an approximate doubling of risk. One study (i3 Ingenix) included patient chart review to confirm the VTE occurrence.