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Ortho Evra® (norelgestromin, ethinyl estradiol transdermal 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.

What are the 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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What are the side effects of Ortho Evra?

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 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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Ortho Evra drug contradictions

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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Ortho Evra FAQs

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.

Can I file a lawsuit if I have suffered damages from taking Ortho Evra?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Ortho Evra, you should contact your doctor immediately. You may also wish to contact an experienced Ortho Evra lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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