Label Changes for:
Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system
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
- Known thrombophilic conditions
- 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
Who Should Not Use Ortho Evra?
- An inherited problem that makes your blood clot more than normal
Other Side Effects
- abnormal taste
- herbal products