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U.S. Department of Health and Human Services

Safety

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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 View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

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...
  • Table 5 (and text following Table 5)

PRECAUTIONS

  • Drug Interactions
    • Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Drugs
      • If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception...
      • Antibiotics
    • Changes in Plasma Levels of Co- Administered Drugs
      • Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine...

PATIENT PACKAGE INSERT

  • Detailed Patient Labeling
    • General Precautions
      • Drug Interactions
        • Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures so your physician may need to adjust the dose...
    • Other Information
      • Special Precautions for Storage and Disposal
         

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.