Label Changes for:

Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system

December 2009

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

CONTRAINDICATIONS 

  • Known thrombophilic conditions 

PRECAUTIONS 

  • Addition of non-nucleoside reverse transcriptase inhibitors as a class of drugs that can significantly change (increase or decrease) the plasma concentrations of estrogen and progestin 
  • Addition of voriconazole, fluconazole, grapefruit juice, and rosuvastatin as additional examples of drugs or foods that may increase the plasma concentration of ethinyl estradiol 

ADVERSE REACTIONS 

Postmarketing Experience 
  • dysguesia

PATIENT LABEL 

Who Should Not Use Ortho Evra? 
  • An inherited problem that makes your blood clot more than normal 
Other Side Effects 
  • abnormal taste 
Drug Interactions
  • herbal products
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