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U.S. Department of Health and Human Services

Safety

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Ortho Evra (norelgestromin/ ethinyl estradiol) transdermal system

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

 

July 2011

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • ...increased appetite

PATIENT PACKAGE INSERT

Other Side Effects
  • ...increased appetite

 

March 2011

Summary View

BOXED WARNING

  • regarding cigarette smoking and the associated risk of serious cardiovascular events has been modified to be consistent with current labeling for combination hormonal contraceptives
Risk of Venous Thromboembolism (moved from Warnings)
  • The risk of venous thromboembolism (VTE) among women aged 15-44 who used the Ortho Evra patch compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic healthcare claims data. The odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased risk of VTE for current users of Ortho evra 

 

April 2010 

Summary View

WARNINGS

Table 5: Estimates (Odds Ratios) of Venous Thromboembolism Risk in Current Users of Ortho Evra Compared to Oral Contraceptive Users.

  • The revision is based on an additional 24 months of data from the i3 Ingenix Study and data from a new post-marketing study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP).
  • The additional data from the i3 Ingenix Study revises the Odds Ratio for venous thromboembolism risk and the confidence interval around the Odds Ratio reported in Table 5 from 2.5 (1.1 – 5.5) to 2.2 (1.2 – 4.0).