Generic: Norelgestromin/Ethinyl Estradiol Patch
Manufacturer: Ortho-McNeil Pharmaceutical
Date approved: November 2001
Status: Prescription only
Approved uses: Birth control
Off-Label uses: Severe acne
• Potentially Fatal Blood Clots
• Pulmonary Embolism
• Heart Attack
Common Misspellings: OrthoEvra
Ortho Evra Contraceptive Patch Side Effects
Ortho Evra, or the birth control patch, is a hormonal contraceptive that uses a skin patch to transmit progestin and estrogen to the blood stream. While the hormones used in Ortho Evra are similar to those used in oral contraceptives, side effects can be more common and severe than in the birth control pill. Women who use Ortho Evra are at increased risk for possibly lethal blood clotting, pulmonary embolism, stroke and heart attack. More frequent side effects include headache, nausea, breast tenderness or enlargement, cramps, bloating and changes to the menstrual cycle.
Ortho-Evra Can Cause Serious Effects
Millions of women use various forms of birth control to prevent against unwanted pregnancy and/or to relieve the effects of heavy and painful menstrual cycles and to regulate their menstrual cycles. One of the most common forms of birth control, and one many women are familiar with, is the birth control pill, comprised of a combination of estrogen and progestin generally taken orally once daily. However, there are many other forms of birth control on the market, some of which are specifically designed to combat problems associated with the daily birth control pill, specifically, forgetfulness. One such medication is Ortho-Evra, the birth control patch.
Ortho-Evra is considered more convenient than the pill because it is a patch applied to the skin once a week, three weeks a month, eliminating the need to remember to take a pill orally every day. Since Ortho-Evra is a patch that is changed once a week, it decreases the chances associated with typical birth control pills that a woman might miss one or more daily doses. For women who have a problem remembering to take the pill, the patch at first appeared to be a viable solution. Problems associated with forgetting to take daily birth control pills include but are not limited to spotting, cramps, nausea (when patients have to “double up” the next day), and in the most serious of cases, unwanted and/or unplanned pregnancy. Alternatives to the daily birth control pill were needed.
Manufactured by Ortho-McNeil Pharmaceutical Inc. Ortho-Evra is the first transdermal (skin) patch approved for birth control. Ortho-Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progrestin and estrogen, respectively) through the skin and into the bloodstream to prevent pregnancy. Unlike oral medication, which is metabolized by the body’s digestive system, the progestin and estrogen in the patch are delivered through the transdermal patch and released directly into the bloodstream.
According to the Federal Drug Agency (FDA), some common side effects with combination hormonal contraceptives like Ortho-Evra are:
• Breast tenderness and enlargement
• Menstrual changes
• Abdominal cramps and bloating
Ortho-Evra contains the same ingredients as oral combination hormonal birth control, so both patients and people in the medical community initially felt very comfortable with the patch, and confident it would work in similar ways. Additionally, the similarity has led many to believe that the patch would not be associated with any additional negative side effects. Familiarity with the ingredients wrongly gave the community a sense of trust in this new form of birth control.
After the Food and Drug Administration approved Ortho-Evra for use in November, 2001 and prescriptions started being written in April 2002, reports surfaced that some very severe and potentially fatal side effects may be associated with the use of the patch.
Although the manufacturer’s Ortho-Evra birth control patch contains the same combination of ingredients as oral combination hormonal birth control products, clinical trial data obtained from the FDA by the Associated Press (AP) suggests that women using the patch have a significantly increased risk of potentially fatal blood clot injuries over those using an oral contraceptive. These injuries include but are not limited to:
• Pulmonary embolism
• Heart attack
The serious side effects of the Ortho-Evra patch continue to be monitored.
Reports of Deaths Associated to Ortho-Evra “Patch”
The safety of the Ortho-Evra birth control patch has been questioned in the past couple of years after the Associated Press reported that research reports surfaced about 23 deaths related to the patch. Doctors who reviewed the 23 cases of death found about 17 deaths that appeared to be clot-related, including 12 deaths from 2004. Roughly a dozen women, mostly in their teens and early twenties, died in 2004 from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other blood clot related events.
Due to the startling and serious adverse side effects associated with the use of Ortho-Evra, the FDA addressed the issue and requested changes be made to the birth control’s label in order to reflect the newfound knowledge. In November 2005 a new label was created. The new bolded warning specifically states that women who use Ortho Evra are exposed to approximately 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho-Evra than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Ortho-Evra. Additionally, because the product labeling for the Ortho-Evra patch included claims that it was just as safe as “the pill,” the FDA required Johnson and Johnson add a warning in November 2005 about the increased risk of injury due to high levels of estrogenreleased from the Ortho Evra patch.
As with traditional oral contraceptives, women who smoke 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. It is recommended that women who use hormonal birth control methods should not smoke.
Ortho Evra should not be used by women who have a history of:
• Heart attack or stroke.
• Blood clots in the legs, lungs (pulmonary embolism), or eyes.
• Blood clots in the deep veins of the legs.
• Chest pain.
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina.
• Current unexplained vaginal bleeding.
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives.
• Liver tumor (benign or cancerous).
• Current or suspected pregnancy.
• Severe high blood pressure.
• Diabetes with complications of the kidneys, eyes, nerves, or blood vessels.
• An allergy to Ortho Evra or to any of its ingredients.
The FDA, together with Ortho-McNeil Pharmaceuticals Inc., continues to monitor the use and side effects of Ortho-Evra.