4/17/2006
Ortho Evra

What is Ortho Evra?

Ortho Evra is a popular transdermal contraceptive patch that may be applied to the arms, torso, abdomen, or buttocks once a week for 3 consecutive weeks. No patch is worn the 4th week. It is manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson. The patch releases ethinyl estradiol (an estrogen) and norelgestromin (a progestin hormone) through the skin into the blood stream. The hormones help prevent ovulation and cause a thickening of the cervical mucus to prevent sperm from entering the uterus.

Ortho Evra Label Change

In November 2005 the U.S. Food and Drug Administration mandated a label change warning that the patch may expose the user to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Higher estrogen levels may put some women at risk for blood clots, stroke, and heart attack.

Risks of Serious Side Effects Are Greatly Increased in Women Who:

Smoke (and risk increases with age and heavy smoking 15 or more cigarettes per day)
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
Have a current or suspected pregnancy

The FDA advises that women with these conditions should not use Ortho Evra.

WARNING SIGNALS

If any of these adverse effects occur while you are using ORTHO EVRA., call your doctor immediately:

Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
Pain in the calf (indicating a possible clot in the leg)
Crushing chest pain or tightness in the chest (indicating a possible heart attack)
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
Sudden partial or complete loss of vision (indicating a possible clot in the eye)
Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)
Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)

Users should consult their health care professional about continued use of the patch.

More information can be found at www.fda.gov or by calling the Center for Drug’s Division of Drug Information at 888-INFO-FDA- (888-463-6332) or emailing druginfo@cder.fda.gov.

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