Ortho Evra is a contraceptive (birth control) skin patch used to prevent pregnancy. It is called a combination hormonal contraceptive because it contains two hormones, estrogen and progestin. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Who should not take Ortho Evra?
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal birth control methods should not smoke.
Ortho Evra should not be used by women who have a history of:
- Extremely high blood pressure
- Benign or cancerous tumor in the liver
- Heart disease including heart attack and stroke
- Breast cancer and cancer in the uterus, vagina, or cervix area
- Blood clots in the lungs and legs
- Yellowing of the eyes or skin during pregnancy or during the previous use of hormonal contraceptives
- Frequent abdominal or chest pain
- Allergies to Ortho Evra or any of its ingredients
- Current or suspected pregnancy
- Diabetes that causes complications in the blood vessels, nerves, or kidneys
General Precautions with Ortho Evra
For the majority of women, Ortho Evra can be used safely. But some women are at high risk of developing certain serious diseases that can be life threatening or that may cause temporary or permanent disability or death. The risks associated with using Ortho Evra increase significantly if you:
- Have high blood pressure, diabetes, or high cholesterol
- Have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors
Ortho Evra may be less effective in preventing pregnancy in women weighing more than 198 pounds.
What should I tell my healthcare provider?
Tell your healthcare provider:
- About all your medical conditions
- If you smoke cigarettes
- About all the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements. Some medicines can affect Ortho Evra and make it less effective.
What are some possible side effects of Ortho Evra?
Some common side effects of combination hormonal contraceptives like Ortho Evra are:
- Breast tenderness and enlargement
- Menstrual changes
- Abdominal cramps and bloating
- Vaginal discharge
- Skin irritation at the application site
This is not a complete list of side effects reported with Ortho Evra. Your healthcare provider can discuss with you a more complete list of side effects.
As a result of further analysis by the FDA and the manufacturer, it has been found that users of Ortho Evra are exposed to about 60% more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the highest blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious side effects.
For more detailed information about Ortho Evra, ask your healthcare provider and pharmacist.
While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible for any injuries caused by a dangerous or defective product under a legal theory called "product liability."
If you or a loved one has experienced any serious complications or unusual medical conditions related to Ortho Evra use, you should first contact your doctor or other healthcare professional. You may also want to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy.
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