Label Changes for:

Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system

September 2009

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

WARNINGS

  • Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism.
  • 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 Orotho Evra. These studies (see Table 5) used slightly different
    designs and reported odds ratios ranging from 0.9 to 2.5. 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.
  • New corresponding table (Table 5).
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