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
