ORTHO EVRA

FDA has approved changes to the Ortho Evra label to include the results of an additional epidemiology study designed to evaluate the risk of developing serious blood clots, also known as venous thromboembolism (VTE), among women aged 15-44 when using Ortho Evra.

Like other methods of birth control, the birth control patch releases hormones. Hormones are chemicals made in our bodies. They control how different parts of our bodies work.

The hormones in the patch are the same hormones as in the birth control pill — estrogen and progestin.

The hormones work by keeping a woman’s ovaries from releasing eggs — ovulation. Pregnancy cannot happen if there is no egg to join with sperm. The hormones in the Ortho Evra patch also prevent pregnancy by thickening a woman’s cervical mucus. The mucus blocks sperm and keeps it from joining with an egg.

The hormones also thin the lining of the uterus. In theory, this could prevent pregnancy by keeping a fertilized egg from attaching to the uterus.

Who should not use ORTHO EVRA®?
Do not use ORTHO EVRA® if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you smoke. You should not use ORTHO EVRA® if you are pregnant or think you may be pregnant or if you have any of the following conditions:

• A history of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of your legs
• An inherited problem that makes your blood clot more than normal
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
• Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
• Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives
• Liver tumor (benign or cancerous)
• Known or suspected pregnancy
• Severe high blood pressure
• Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
• Headaches with neurological symptoms
• Use of oral contraceptives (birth control pills)
• Disease of heart valves with complications
• Need for a prolonged bed rest following major surgery
• An allergic reaction to any of the components of ORTHO EVRA®

Tell your healthcare professional if you have ever had any of these conditions. Your healthcare professional can recommend a non-hormonal method of birth control.

• Skin irritation at the site of application. If this occurs, remove the Patch and apply a new patch at a new location until the next Change Day. Single replacement patches are available from pharmacies.
• Irregular vaginal bleeding or spotting. If bleeding occurs in more than a few cycles or lasts for more than a few days, call your healthcare professional.
• Problems wearing contact lenses such as change in vision or inability to wear your lenses. If these occur, contact your healthcare professional.
• Edema (fluid retention) in the ankles or fingers and/or a rise in blood pressure. Contact your healthcare professional if you experience fluid retention.
• Spotty darkening of the skin (particularly on the face). This may persist after you stop using ORTHO EVRA®.
• Other side effects: weight gain, feeling dizzy, migraine, stomach pain or bloating, vomiting, diarrhea, acne, muscle spasms, vaginal infections, tiredness, painful or heavy periods, more frequent periods, uterine cramps, vaginal discharge, and mood problems such as mood swings, depression or anxiety.

The most common side effects are nausea, breast symptoms (engorgement, pain or discomfort), headache, and problems where the patch has been on the skin.