Safety & Side Effects
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Ortho Women's Health & Urology™ Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has updated the prescribing information for ORTHO EVRA®, the only weekly birth control patch. The FDA worked closely with Ortho Women's Health & Urology™ to develop the new language.
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack, blood clots, or stroke, as well as those who are or may be pregnant.
Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30–35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills.
You should discuss with your healthcare professional whether ORTHO EVRA® is a good method of contraception
for you.
The Patch does not protect against HIV or sexually transmitted diseases.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the Detailed Patient Labeling from the full Product Information.
In clinical trials, the most frequent adverse events leading to discontinuation in 1.0% to 2.4% of women included nausea and/or vomiting, application site reaction, breast symptoms, headache and emotional changes.
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack, blood clots or stroke, as well as those who are or may be pregnant.
Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills.
You should discuss with your healthcare professional whether ORTHO EVRA® is a good method of contraception for you.The Patch does not protect against HIV or sexually transmitted diseases.
If you are pregnant, or think you may become pregnant, you should not use the birth control patch. In addition, you should not use ORTHO EVRA® 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
- 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 such as ORTHO EVRA®, Norplant®*, or the birth control pill
- 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 period of bed rest following major surgery
- An allergic reaction to any of the components of ORTHO EVRA®
Tell your doctor or healthcare professional if you have ever had any of these conditions. He or she can recommend a non–hormonal method of birth control.
*Norplant is a registered trademark of Wyeth.
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Can't sleep? Flip your mattress for a comfy new bed.
Chewing gum stuck in the carpet? Rub it with an ice cube until hard, then just pull it off.
Breath not as fresh as you'd like? Remember to brush your tongue, too.
