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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 2009

 

Summary View

 

CONTRAINDICATIONS

  • The term “significant hypertension” was replaced with actual blood pressure values

WARNINGS

Elevated Blood Pressure
  • Providing more complete guidance to healthcare providers regarding use in women with hypertension

ADVERSE REACTIONS

Clinical Trial Experience, Postmarketing Experience
  • editorial revisions to provide for use of MedDRA terminology and a more user-friendly format
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