"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in females. In case of suspected overdose, all ORTHO EVRA patches should be removed and symptomatic treatment given.
Do not prescribe ORTHO EVRA to women who are known to have the following conditions:
- A high risk of arterial or venous thrombotic diseases.
Examples include women who are known to:
- Smoke, if over age 35 [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]
- Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS]
- Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS]
- Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS]
- Have coronary artery disease [see WARNINGS AND PRECAUTIONS]
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS]
- Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
- Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS]
- Have headaches with focal neurological symptoms or have migraine
headaches with aura
- Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS]
- Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY]
- Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS]
- Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]
- Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS]
Last reviewed on RxList: 7/12/2013
Additional Ortho Evra Information
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