Ortho Evra Birth Control Patch:

Ortho Evra, manufactured by Ortho McNeil Pharmaceuticals, is a weekly prescription method of birth control. It is a thin, beige, plastic patch that sticks to the skin and releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) into the blood stream.  Ortho Evra helps prevent pregnancy the same way birth control pills do: by preventing ovulation and by thickening the cervical mucus--making it more difficult for sperm to enter the uterus.

Ortho Evra Prescription:

Ortho Evra is a transdermal (skin) weekly birth control patch that is prescribed to prevent pregnancy by delivering continuous levels of the hormones norelgestromin and ethinyl estradiol (progestin and estrogen) through the skin and into the bloodstream.

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FDA NEWS UPDATE FOR ORTHO EVRA: 1/21/2008.

FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#orthoevrapatch

 

 

FDA Approved Uses For Ortho Evra

In 2001, the FDA approved Ortho Evra, the first transdermal patch approved for birth control. The weekly prescription patch releases norelgestromin and ethinyl estradiol to prevent ovulation and pregnancy.

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Ortho Evra Side Effects

Common side effects associated with Ortho Evra include nausea, vomiting, headache, redness or itching at the patch application site, dizziness, breast tenderness, vaginal discomfort/irritation, and stomach cramping/bloating.

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Ortho Evra Warnings and FDA Alerts

In 2005, the FDA approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels (60% more) of estrogen than most birth control pills. High estrogen levels are linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks, pulmonary embolisms, and deep vein thromboses (DVTs).

Hormones from patches applied to the skin, such as Ortho Evra, get into the blood stream quicker and are removed from the body differently than hormones from birth control pills taken by mouth. According to the AP, about a dozen women, most of them in their late teens and early 20's, died from blood clots in 2004 from using the Ortho Evra patch.

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Drug Contraindications of Ortho Evra:

Ortho Evra is contraindicated in patients who use various antibiotics, antifungals, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids.

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FAQ's on Ortho Evra:

Who should NOT use Ortho Evra?

If you are pregnant, or think you may become pregnant, you should not use Ortho Evra. In addition, you should not use Ortho Evra if you have any of the following conditions:

• History of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• 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 healthcare professional 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)
• Severe high blood pressure
• Diabetes with complications of the kidneys, eyes, nerves or blood vessels
• Headaches with neurological symptoms
• Disease of heart valves with complications
• Need for a prolonged period of bed rest following major surgery

Can other medications have a negative effect with Ortho Evra?

Certain drugs may interact with Ortho Evra and other hormonal contraceptives, making them less effective in preventing pregnancy and possibly causing an increase in breakthrough bleeding. Such drugs include:

• Rifampin
• Drugs for epilepsy, such as barbiturates (eg, phenobarbital) and anticonvulsants, including topiramate, carbamazepine, phenytoin
• Certain drugs used in the treatment of HIV/AIDS
• Certain antibiotics
• Herbal products containing St. John's wort

How effective is Ortho Evra in preventing pregnancy?

When used correctly, Ortho Evra is 99% effective, just like birth control pills.

Can a woman decrease the amount of estrogen from the Ortho Evra patch by cutting the patch and applying only a part of the patch?

No.  The patch should not be cut.  If cut or altered, Ortho Evra will not protect against pregnancy.

I have experienced health problems from using Ortho Evra. Should I contact an attorney?

It may be important for you to contact an attorney who can help you protect your legal rights. An experienced defective drug litigation attorney can evaluate whether you have a claim that is worth pursuing. There may be time limits for you to file a claim, however, (statute of limitations), and you may forfeit your right to compensation if you delay.

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